Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01533207
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 38
• Locations: 623
• Arms: 2
• Actual Duration (Months): 80.2
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Condition or Disease	Intervention/Treatment	Phase
Stage I Uterine Sarcoma AJCC v7; Uterine Corpus Leiomyosarcoma	Other: Clinical Observation; Drug: Docetaxel; Drug: Doxorubicin Hydrochloride; Biological: Filgrastim; Drug: Gemcitabine Hydrochloride; Biological: Pegfilgrastim	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride (gemcitabine) plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation.

SECONDARY OBJECTIVES:

1. To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.

2. To explore the impact of potential predictors of recurrence or death such as patient age, institution reported tumor size, cervix involvement (yes or no), and mitotic rate.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo computed tomography (CT) and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.

Arm II: Patients undergo clinical observation.

After completion of study treatment, patients in both arms are followed up every 4 months for 3 years and then every 6 months for 2 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma
• Actual Study Start Date: Jun 4, 2012
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Feb 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (chemotherapy) Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT and/or MRI. Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.	Drug: Docetaxel; Given IV; Other Names: Docecad RP56976 Taxotere Taxotere Injection Concentrate ; Drug: Doxorubicin Hydrochloride; Given IV; Other Names: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI) ADM Adriacin Adriamycin Adriamycin Hydrochloride Adriamycin PFS Adriamycin RDF ADRIAMYCIN, HYDROCHLORIDE Adriamycine Adriblastina Adriblastine Adrimedac Chloridrato de Doxorrubicina DOX DOXO-CELL Doxolem Doxorubicin.HCl Doxorubin Farmiblastina FI 106 FI-106 hydroxydaunorubicin Rubex ; Biological: Filgrastim; Given subcutaneously (SC); Other Names: FILGRASTIM, LICENSE HOLDER UNSPECIFIED G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tevagrastim ; Drug: Gemcitabine Hydrochloride; Given IV; Other Names: dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011 LY188011 ; Biological: Pegfilgrastim; Given SC; Other Names: Filgrastim SD-01 filgrastim-SD/01 Fulphila HSP-130 Jinyouli Neulasta Neulastim Pegfilgrastim Biosimilar HSP-130 SD-01 SD-01 sustained duration G-CSF
Other: Arm II (no treatment) Patients undergo clinical observation.	Other: Clinical Observation; Patients followed clinically; Other Names: observation

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Death [Follow-up every 4 months for 3 years, then every 6 months for 2 years.]

   The duration of time from study entry to time of death or the date of last contact.

Secondary Outcome Measures

1. Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [Approximately 4 years]

2. Number of Participants With Recurrence [Follow-up every 4 months for 3 years, then every 6 months for 2 years.]

   The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.

Other Outcome Measures

1. Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors [Up to 5 years]

   Analyses will be carried out using proportional hazards models of both survival and recurrence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with high-risk uterine leiomyosarcoma (LMS), Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy is not required

• Institutional pathology review calls the uterine leiomyosarcoma ?high grade?

• Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field

• All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or bilateral salpingo-oophorectomy (BSO), the 12 weeks may be counted from the time of the second operation

• Patients who had a ?morcellation? hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma

• All patients must have no evidence of persistent or metastatic disease as documented by a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CT chest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imaging studies should be performed within 4 weeks of registration on study

• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL (ANC >= 1.5 x 10^9/liter [L])

• Platelets greater than or equal to 100,000/mcL (platelets >= 100 x 10^9/L)

• Hemoglobin greater than 8.0 g/dL (= 80 g/L or 4.9 mmol/L)

• Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)

• Bilirubin* within normal range

• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])* and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])* less than or equal to 2.5 times ULN

• Alkaline phosphatase* less than or equal to 2.5 x ULN

• • Patients with a history of Gilbert?s syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed

• Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1

• Patients with Gynecologic Oncology Group (GOG) performance status of 0 or 1 OR Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky performance status (PS) >= 80%

• Patients who have met the pre-entry requirements specified

• Patients must have signed an approved informed consent

• Patients participating through United States (U.S.) sites must sign an approved and authorization permitting release of personal health information

• Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])

Exclusion Criteria:

• Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history

• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy

• Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel) or other drugs formulated with polysorbate 80

• Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3 or 4

• Patients who are breast-feeding

• Patients with a known history of congestive heart failure or cardiac ejection fraction < 50% (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 of gemcitabine-docetaxel treatment

• Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50% or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I

• Patients with a history of prior whole pelvic radiation

• Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician; documentation of concurrent medications is required

• Patients with recurrent uterine LMS

• Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible

• Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Valley Gynecologic Oncology	Huntsville	Alabama	United States	35805
2	Anchorage Associates in Radiation Medicine	Anchorage	Alaska	United States	98508
3	Anchorage Radiation Therapy Center	Anchorage	Alaska	United States	99504
4	Alaska Breast Care and Surgery LLC	Anchorage	Alaska	United States	99508
5	Alaska Oncology and Hematology LLC	Anchorage	Alaska	United States	99508
6	Alaska Regional Hospital	Anchorage	Alaska	United States	99508
7	Alaska Women's Cancer Care	Anchorage	Alaska	United States	99508
8	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
9	Katmai Oncology Group	Anchorage	Alaska	United States	99508
10	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
11	Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
12	CHI Saint Vincent Cancer Center Hot Springs	Hot Springs	Arkansas	United States	71913
13	Kaiser Permanente-Deer Valley Medical Center	Antioch	California	United States	94531
14	Sutter Auburn Faith Hospital	Auburn	California	United States	95602
15	Sutter Cancer Centers Radiation Oncology Services-Auburn	Auburn	California	United States	95603
16	Alta Bates Summit Medical Center-Herrick Campus	Berkeley	California	United States	94704
17	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California	United States	91505
18	Mills-Peninsula Medical Center	Burlingame	California	United States	94010
19	Sutter Cancer Centers Radiation Oncology Services-Cameron Park	Cameron Park	California	United States	95682
20	Sutter Davis Hospital	Davis	California	United States	95616
21	Kaiser Permanente-Fremont	Fremont	California	United States	94538
22	Kaiser Permanente-Fresno	Fresno	California	United States	93720
23	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
24	Loma Linda University Medical Center	Loma Linda	California	United States	92354
25	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
26	Memorial Medical Center	Modesto	California	United States	95355
27	Kaiser Permanente-Modesto	Modesto	California	United States	95356
28	Palo Alto Medical Foundation-Camino Division	Mountain View	California	United States	94040
29	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California	United States	94040
30	Sutter Cancer Research Consortium	Novato	California	United States	94945
31	Kaiser Permanente-Oakland	Oakland	California	United States	94611
32	Palo Alto Medical Foundation Health Care	Palo Alto	California	United States	94301
33	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
34	Kaiser Permanente-Richmond	Richmond	California	United States	94801
35	Kaiser Permanente-Roseville	Roseville	California	United States	95661
36	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California	United States	95661
37	Sutter Roseville Medical Center	Roseville	California	United States	95661
38	Sutter Medical Center Sacramento	Sacramento	California	United States	95816
39	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
40	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
41	Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110
42	California Pacific Medical Center-Pacific Campus	San Francisco	California	United States	94115
43	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
44	UCSF Medical Center-Mission Bay	San Francisco	California	United States	94158
45	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
46	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
47	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
48	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
49	Palo Alto Medical Foundation-Santa Cruz	Santa Cruz	California	United States	95065
50	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
51	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
52	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
53	Kaiser Permanente-Stockton	Stockton	California	United States	95210
54	Palo Alto Medical Foundation-Sunnyvale	Sunnyvale	California	United States	94086
55	Olive View-University of California Los Angeles Medical Center	Sylmar	California	United States	91342
56	Sutter Cancer Centers Radiation Oncology Services-Vacaville	Vacaville	California	United States	95687
57	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
58	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
59	Sutter Solano Medical Center/Cancer Center	Vallejo	California	United States	94589
60	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
61	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	United States	80012
62	The Medical Center of Aurora	Aurora	Colorado	United States	80012
63	University of Colorado Hospital	Aurora	Colorado	United States	80045
64	Boulder Community Hospital	Boulder	Colorado	United States	80301
65	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado	United States	80304
66	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
67	Rocky Mountain Cancer Centers-Penrose	Colorado Springs	Colorado	United States	80907
68	Porter Adventist Hospital	Denver	Colorado	United States	80210
69	Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
70	Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado	United States	80218
71	Rocky Mountain Cancer Centers-Midtown	Denver	Colorado	United States	80218
72	SCL Health Saint Joseph Hospital	Denver	Colorado	United States	80218
73	Rocky Mountain Cancer Centers-Rose	Denver	Colorado	United States	80220
74	Rose Medical Center	Denver	Colorado	United States	80220
75	Colorado Cancer Research Program NCORP	Denver	Colorado	United States	80222
76	Mercy Medical Center	Durango	Colorado	United States	81301
77	Southwest Oncology PC	Durango	Colorado	United States	81301
78	Comprehensive Cancer Care and Research Institute of Colorado LLC	Englewood	Colorado	United States	80113
79	Swedish Medical Center	Englewood	Colorado	United States	80113
80	Mountain Blue Cancer Care Center	Golden	Colorado	United States	80401
81	North Colorado Medical Center	Greeley	Colorado	United States	80631
82	Rocky Mountain Cancer Centers-Greenwood Village	Greenwood Village	Colorado	United States	80111
83	Rocky Mountain Cancer Centers-Lakewood	Lakewood	Colorado	United States	80228
84	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
85	Rocky Mountain Cancer Centers-Littleton	Littleton	Colorado	United States	80120
86	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
87	Rocky Mountain Cancer Centers-Sky Ridge	Lone Tree	Colorado	United States	80124
88	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
89	Longmont United Hospital	Longmont	Colorado	United States	80501
90	Rocky Mountain Cancer Centers-Longmont	Longmont	Colorado	United States	80501
91	McKee Medical Center	Loveland	Colorado	United States	80539
92	Parker Adventist Hospital	Parker	Colorado	United States	80138
93	Rocky Mountain Cancer Centers-Parker	Parker	Colorado	United States	80138
94	Saint Mary Corwin Medical Center	Pueblo	Colorado	United States	81004
95	Rocky Mountain Cancer Centers - Pueblo	Pueblo	Colorado	United States	81008
96	Rocky Mountain Cancer Centers-Thornton	Thornton	Colorado	United States	80260
97	SCL Health Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
98	Hartford Hospital	Hartford	Connecticut	United States	06102
99	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
100	Beebe Medical Center	Lewes	Delaware	United States	19958
101	Christiana Gynecologic Oncology LLC	Newark	Delaware	United States	19713
102	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
103	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
104	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
105	Regional Hematology and Oncology PA	Newark	Delaware	United States	19713
106	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
107	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
108	Nanticoke Memorial Hospital	Seaford	Delaware	United States	19973
109	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware	United States	19801
110	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
111	Florida Hospital Cancer Institute Altamonte	Altamonte Springs	Florida	United States	32701
112	Florida Hospital Kissimmee	Kissimmee	Florida	United States	34744
113	Florida Hospital Orlando	Orlando	Florida	United States	32803
114	Florida Urology Associates-Orlando	Orlando	Florida	United States	32803
115	Florida Hospital East Orlando	Orlando	Florida	United States	32822
116	Florida Hospital Cancer Institute Winter Park	Winter Park	Florida	United States	32792
117	Piedmont Hospital	Atlanta	Georgia	United States	30309
118	Northside Hospital	Atlanta	Georgia	United States	30342
119	Dekalb Medical Center	Decatur	Georgia	United States	30033
120	Northeast Georgia Medical Center-Gainesville	Gainesville	Georgia	United States	30501
121	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
122	Summit Cancer Care-Memorial	Savannah	Georgia	United States	31404
123	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
124	Low Country Cancer Care Associates PC	Savannah	Georgia	United States	31405
125	Hawaii Oncology Inc-Pali Momi	'Aiea	Hawaii	United States	96701
126	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
127	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii	United States	96701
128	Hawaii Cancer Care Inc-POB II	Honolulu	Hawaii	United States	96813
129	Hawaii Oncology Inc-POB I	Honolulu	Hawaii	United States	96813
130	Island Urology	Honolulu	Hawaii	United States	96813
131	Queen's Medical Center	Honolulu	Hawaii	United States	96813
132	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
133	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
134	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii	United States	96817
135	Hawaii Oncology Inc-Kuakini	Honolulu	Hawaii	United States	96817
136	Kuakini Medical Center	Honolulu	Hawaii	United States	96817
137	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
138	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii	United States	96819
139	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
140	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
141	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
142	Saint Luke's Mountain States Tumor Institute	Boise	Idaho	United States	83712
143	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
144	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho	United States	83619
145	Saint Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
146	Saint Luke's Mountain States Tumor Institute - Meridian	Meridian	Idaho	United States	83642
147	Saint Luke's Mountain States Tumor Institute - Nampa	Nampa	Idaho	United States	83686
148	Kootenai Cancer Center	Post Falls	Idaho	United States	83854
149	Kootenai Cancer Clinic	Sandpoint	Idaho	United States	83864
150	Saint Luke's Mountain States Tumor Institute-Twin Falls	Twin Falls	Idaho	United States	83301
151	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
152	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
153	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
154	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
155	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
156	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
157	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
158	Mount Sinai Hospital Medical Center	Chicago	Illinois	United States	60608
159	Northwestern University	Chicago	Illinois	United States	60611
160	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
161	Rush University Medical Center	Chicago	Illinois	United States	60612
162	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
163	Carle on Vermilion	Danville	Illinois	United States	61832
164	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
165	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
166	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
167	Crossroads Cancer Center	Effingham	Illinois	United States	62401
168	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
169	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois	United States	60201
170	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
171	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
172	Sudarshan K Sharma MD Limited-Gynecologic Oncology	Hinsdale	Illinois	United States	60521
173	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
174	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
175	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
176	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
177	UC Comprehensive Cancer Center at Silver Cross	New Lenox	Illinois	United States	60451
178	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
179	Radiation Oncology of Northern Illinois	Ottawa	Illinois	United States	61350
180	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
181	OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
182	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
183	OSF Saint Francis Radiation Oncology at Peoria Cancer Center	Peoria	Illinois	United States	61615
184	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
185	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
186	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
187	Valley Radiation Oncology	Peru	Illinois	United States	61354
188	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
189	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62702
190	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
191	Springfield Clinic	Springfield	Illinois	United States	62702
192	Memorial Medical Center	Springfield	Illinois	United States	62781
193	Cancer Care Specialists of Illinois-Swansea	Swansea	Illinois	United States	62226
194	Carle Cancer Center	Urbana	Illinois	United States	61801
195	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
196	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
197	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana	United States	46260
198	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
199	Woodland Cancer Care Center	Michigan City	Indiana	United States	46360
200	Memorial Regional Cancer Center Day Road	Mishawaka	Indiana	United States	46545
201	Reid Health	Richmond	Indiana	United States	47374
202	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
203	Mary Greeley Medical Center	Ames	Iowa	United States	50010
204	McFarland Clinic PC - Ames	Ames	Iowa	United States	50010
205	McFarland Clinic PC-Boone	Boone	Iowa	United States	50036
206	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
207	Mercy Cancer Center-West Lakes	Clive	Iowa	United States	50325
208	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
209	Greater Regional Medical Center	Creston	Iowa	United States	50801
210	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
211	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa	United States	50309
212	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
213	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
214	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
215	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
216	McFarland Clinic PC-Trinity Cancer Center	Fort Dodge	Iowa	United States	50501
217	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
218	McFarland Clinic PC-Jefferson	Jefferson	Iowa	United States	50129
219	McFarland Clinic PC-Marshalltown	Marshalltown	Iowa	United States	50158
220	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
221	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51102
222	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
223	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
224	Mercy Medical Center-West Lakes	West Des Moines	Iowa	United States	50266
225	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
226	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
227	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
228	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
229	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
230	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
231	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
232	Kansas Institute of Medicine Cancer and Blood Center	Lenexa	Kansas	United States	66219
233	Minimally Invasive Surgery Hospital	Lenexa	Kansas	United States	66219
234	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67905
235	Cancer Center of Kansas-Manhattan	Manhattan	Kansas	United States	66502
236	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
237	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
238	Menorah Medical Center	Overland Park	Kansas	United States	66209
239	Saint Luke's South Hospital	Overland Park	Kansas	United States	66213
240	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
241	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas	United States	66208
242	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
243	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
244	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
245	Associates In Womens Health	Wichita	Kansas	United States	67208
246	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
247	Cancer Center of Kansas - Wichita	Wichita	Kansas	United States	67214
248	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
249	Wesley Medical Center	Wichita	Kansas	United States	67214
250	Wichita NCI Community Oncology Research Program	Wichita	Kansas	United States	67214
251	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
252	Flaget Memorial Hospital	Bardstown	Kentucky	United States	40004
253	Commonwealth Cancer Center-Corbin	Corbin	Kentucky	United States	40701
254	Oncology Hematology Care Inc-Crestview	Crestview Hills	Kentucky	United States	41017
255	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky	United States	40504
256	Saint Joseph Hospital East	Lexington	Kentucky	United States	40509
257	Jewish Hospital	Louisville	Kentucky	United States	40202
258	Saints Mary and Elizabeth Hospital	Louisville	Kentucky	United States	40215
259	Jewish Hospital Medical Center Northeast	Louisville	Kentucky	United States	40245
260	Jewish Hospital Medical Center South	Shepherdsville	Kentucky	United States	40165
261	Woman's Hospital	Baton Rouge	Louisiana	United States	70817
262	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
263	Maine Medical Center- Scarborough Campus	Scarborough	Maine	United States	04074
264	University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
265	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21287
266	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889-5600
267	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
268	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
269	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
270	Baystate Medical Center	Springfield	Massachusetts	United States	01199
271	Bixby Medical Center	Adrian	Michigan	United States	49221
272	Hickman Cancer Center	Adrian	Michigan	United States	49221
273	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
274	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
275	Weisberg Cancer Treatment Center	Farmington Hills	Michigan	United States	48334
276	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
277	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
278	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
279	Mercy Memorial Hospital	Monroe	Michigan	United States	48162
280	Monroe Cancer Center	Monroe	Michigan	United States	48162
281	Toledo Clinic Cancer Centers-Monroe	Monroe	Michigan	United States	48162
282	Saint Dominic-Jackson Memorial Hospital	Jackson	Mississippi	United States	39216
283	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
284	Central Care Cancer Center - Bolivar	Bolivar	Missouri	United States	65613
285	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
286	Cox Cancer Center Branson	Branson	Missouri	United States	65616
287	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
288	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
289	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
290	Capital Region Southwest Campus	Jefferson City	Missouri	United States	65109
291	Freeman Health System	Joplin	Missouri	United States	64804
292	Mercy Hospital Joplin	Joplin	Missouri	United States	64804
293	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
294	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri	United States	64118
295	Research Medical Center	Kansas City	Missouri	United States	64132
296	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
297	Liberty Radiation Oncology Center	Liberty	Missouri	United States	64068
298	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
299	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
300	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64507
301	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
302	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
303	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
304	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
305	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
306	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
307	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
308	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
309	CoxHealth South Hospital	Springfield	Missouri	United States	65807
310	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
311	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
312	Community Hospital of Anaconda	Anaconda	Montana	United States	59711
313	Billings Clinic Cancer Center	Billings	Montana	United States	59101
314	Saint Vincent Healthcare	Billings	Montana	United States	59101
315	Montana Cancer Consortium NCORP	Billings	Montana	United States	59102
316	Saint Vincent Frontier Cancer Center	Billings	Montana	United States	59102
317	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
318	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
319	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
320	Great Falls Clinic	Great Falls	Montana	United States	59405
321	Northern Montana Hospital	Havre	Montana	United States	59501
322	Saint Peter's Community Hospital	Helena	Montana	United States	59601
323	Glacier Oncology PLLC	Kalispell	Montana	United States	59901
324	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
325	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
326	Montana Cancer Specialists	Missoula	Montana	United States	59802
327	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
328	Community Medical Hospital	Missoula	Montana	United States	59804
329	CHI Health Saint Francis	Grand Island	Nebraska	United States	68803
330	Heartland Hematology and Oncology	Kearney	Nebraska	United States	68845
331	CHI Health Good Samaritan	Kearney	Nebraska	United States	68847
332	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
333	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
334	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
335	Hematology and Oncology Consultants PC	Omaha	Nebraska	United States	68122
336	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
337	Alegent Health Lakeside Hospital	Omaha	Nebraska	United States	68130
338	Creighton University Medical Center	Omaha	Nebraska	United States	68131
339	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
340	Midlands Community Hospital	Papillion	Nebraska	United States	68046
341	Women's Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
342	Center of Hope at Renown Medical Center	Reno	Nevada	United States	89502
343	Renown Regional Medical Center	Reno	Nevada	United States	89502
344	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
345	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
346	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
347	Virtua Memorial	Mount Holly	New Jersey	United States	08060
348	MD Anderson Cancer Center at Cooper-Voorhees	Voorhees	New Jersey	United States	08043
349	Virtua Voorhees	Voorhees	New Jersey	United States	08043
350	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
351	Southwest Gynecologic Oncology Associates Inc	Albuquerque	New Mexico	United States	87106
352	Women's Cancer Care Associates LLC	Albany	New York	United States	12208
353	New York-Presbyterian/Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
354	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
355	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
356	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
357	University of Rochester	Rochester	New York	United States	14642
358	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570
359	Memorial Sloan Kettering Sleepy Hollow	Sleepy Hollow	New York	United States	10591
360	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
361	State University of New York Upstate Medical University	Syracuse	New York	United States	13210
362	Randolph Hospital	Asheboro	North Carolina	United States	27203
363	AdventHealth Infusion Center Asheville	Asheville	North Carolina	United States	28803
364	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina	United States	27215
365	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
366	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
367	Oncology Specialists of Charlotte	Charlotte	North Carolina	United States	28207
368	Southern Oncology Specialists-Charlotte	Charlotte	North Carolina	United States	28262
369	Atrium Health Cabarrus/LCI-Concord	Concord	North Carolina	United States	28025
370	Duke University Medical Center	Durham	North Carolina	United States	27710
371	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
372	AdventHealth Hendersonville	Hendersonville	North Carolina	United States	28792
373	Lake Norman Hematology Oncology Specialists-Huntersville	Huntersville	North Carolina	United States	28078
374	Southern Oncology Specialists-Huntersville	Huntersville	North Carolina	United States	28078
375	Matthews Radiation Oncology Center	Matthews	North Carolina	United States	28105
376	Novant Health Cancer Specialists-Matthews	Matthews	North Carolina	United States	28105
377	Cone Heath Cancer Center at Mebane	Mebane	North Carolina	United States	27302
378	Lake Norman Hematology Oncology Specialists-Mooresville	Mooresville	North Carolina	United States	28117
379	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
380	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
381	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
382	Saint Alexius Medical Center	Bismarck	North Dakota	United States	58501
383	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
384	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio	United States	44304
385	UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	United States	44122
386	Strecker Cancer Center-Belpre	Belpre	Ohio	United States	45714
387	Toledo Clinic Cancer Centers-Bowling Green	Bowling Green	Ohio	United States	43402
388	Aultman Health Foundation	Canton	Ohio	United States	44710
389	Dayton Physicians LLC-Miami Valley South	Centerville	Ohio	United States	45459
390	Miami Valley Hospital South	Centerville	Ohio	United States	45459
391	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
392	Oncology Hematology Care Inc-Eden Park	Cincinnati	Ohio	United States	45202
393	Oncology Hematology Care Inc-Mercy West	Cincinnati	Ohio	United States	45211
394	University of Cincinnati/Barrett Cancer Center	Cincinnati	Ohio	United States	45219
395	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio	United States	45220
396	Oncology Hematology Care Inc - Anderson	Cincinnati	Ohio	United States	45230
397	Oncology Hematology Care Inc-Kenwood	Cincinnati	Ohio	United States	45236
398	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
399	Oncology Hematology Care Inc-Blue Ash	Cincinnati	Ohio	United States	45242
400	TriHealth Cancer Institute-Westside	Cincinnati	Ohio	United States	45247
401	TriHealth Cancer Institute-Anderson	Cincinnati	Ohio	United States	45255
402	Case Western Reserve University	Cleveland	Ohio	United States	44106
403	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
404	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio	United States	43214
405	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
406	Columbus NCI Community Oncology Research Program	Columbus	Ohio	United States	43215
407	Grant Medical Center	Columbus	Ohio	United States	43215
408	The Mark H Zangmeister Center	Columbus	Ohio	United States	43219
409	Mount Carmel Health Center West	Columbus	Ohio	United States	43222
410	Doctors Hospital	Columbus	Ohio	United States	43228
411	Grandview Hospital	Dayton	Ohio	United States	45405
412	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
413	Miami Valley Hospital	Dayton	Ohio	United States	45409
414	Dayton Physician LLC-Miami Valley Hospital North	Dayton	Ohio	United States	45415
415	Miami Valley Hospital North	Dayton	Ohio	United States	45415
416	Dayton NCI Community Oncology Research Program	Dayton	Ohio	United States	45420
417	Delaware Health Center-Grady Cancer Center	Delaware	Ohio	United States	43015
418	Delaware Radiation Oncology	Delaware	Ohio	United States	43015
419	Grady Memorial Hospital	Delaware	Ohio	United States	43015
420	Oncology Hematology Care Inc-Healthplex	Fairfield	Ohio	United States	45014
421	Armes Family Cancer Center	Findlay	Ohio	United States	45840
422	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
423	Orion Cancer Care	Findlay	Ohio	United States	45840
424	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
425	Dayton Physicians LLC-Atrium	Franklin	Ohio	United States	45005
426	Dayton Physicians LLC-Wayne	Greenville	Ohio	United States	45331
427	Wayne Hospital	Greenville	Ohio	United States	45331
428	Greater Dayton Cancer Center	Kettering	Ohio	United States	45409
429	Kettering Medical Center	Kettering	Ohio	United States	45429
430	Fairfield Medical Center	Lancaster	Ohio	United States	43130
431	Lancaster Radiation Oncology	Lancaster	Ohio	United States	43130
432	Lima Memorial Hospital	Lima	Ohio	United States	45804
433	Marietta Memorial Hospital	Marietta	Ohio	United States	45750
434	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537
435	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio	United States	43537
436	UH Seidman Cancer Center at Landerbrook Health Center	Mayfield Heights	Ohio	United States	44124
437	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio	United States	44060
438	Dayton Physicians LLC-Signal Point	Middletown	Ohio	United States	45042
439	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
440	Licking Memorial Hospital	Newark	Ohio	United States	43055
441	Newark Radiation Oncology	Newark	Ohio	United States	43055
442	Saint Charles Hospital	Oregon	Ohio	United States	43616
443	Toledo Clinic Cancer Centers-Oregon	Oregon	Ohio	United States	43616
444	Southern Ohio Medical Center	Portsmouth	Ohio	United States	45662
445	Dayton Physicians LLC-Wilson	Sidney	Ohio	United States	45365
446	Springfield Regional Cancer Center	Springfield	Ohio	United States	45504
447	Springfield Regional Medical Center	Springfield	Ohio	United States	45505
448	ProMedica Flower Hospital	Sylvania	Ohio	United States	43560
449	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
450	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
451	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
452	University of Toledo	Toledo	Ohio	United States	43614
453	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio	United States	43617
454	Mercy Saint Anne Hospital	Toledo	Ohio	United States	43623
455	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
456	Dayton Physicians LLC-Upper Valley	Troy	Ohio	United States	45373
457	Upper Valley Medical Center	Troy	Ohio	United States	45373
458	University Hospitals Sharon Health Center	Wadsworth	Ohio	United States	44281
459	Fulton County Health Center	Wauseon	Ohio	United States	43567
460	Saint Ann's Hospital	Westerville	Ohio	United States	43081
461	UHHS-Westlake Medical Center	Westlake	Ohio	United States	44145
462	Wright-Patterson Medical Center	Wright-Patterson Air Force Base	Ohio	United States	45433-5529
463	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio	United States	43701
464	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
465	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
466	Saint Charles Health System	Bend	Oregon	United States	97701
467	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
468	Providence Oncology and Hematology Care Southeast	Clackamas	Oregon	United States	97015
469	Bay Area Hospital	Coos Bay	Oregon	United States	97420
470	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
471	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
472	Providence Willamette Falls Medical Center	Oregon City	Oregon	United States	97045
473	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
474	Providence Portland Medical Center	Portland	Oregon	United States	97213
475	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
476	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
477	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
478	UPMC-Heritage Valley Health System Beaver	Beaver	Pennsylvania	United States	15009
479	Saint Luke's University Hospital-Bethlehem Campus	Bethlehem	Pennsylvania	United States	18015
480	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
481	Easton Hospital	Easton	Pennsylvania	United States	18042
482	Ephrata Cancer Center	Ephrata	Pennsylvania	United States	17522
483	Ephrata Community Hospital	Ephrata	Pennsylvania	United States	17522
484	Adams Cancer Center	Gettysburg	Pennsylvania	United States	17325
485	UPMC Cancer Centers - Arnold Palmer Pavilion	Greensburg	Pennsylvania	United States	15601
486	Cherry Tree Cancer Center	Hanover	Pennsylvania	United States	17331
487	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
488	UPMC-Johnstown/John P. Murtha Regional Cancer Center	Johnstown	Pennsylvania	United States	15901
489	Armstrong Center for Medicine and Health	Kittanning	Pennsylvania	United States	16201
490	UPMC Cancer Center at UPMC McKeesport	McKeesport	Pennsylvania	United States	15132
491	UPMC-Coraopolis/Heritage Valley Radiation Oncology	Moon	Pennsylvania	United States	15108
492	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301
493	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
494	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
495	UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
496	UPMC-Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
497	UPMC-Saint Margaret	Pittsburgh	Pennsylvania	United States	15215
498	West Penn Hospital	Pittsburgh	Pennsylvania	United States	15224
499	University of Pittsburgh Cancer Institute (UPCI)	Pittsburgh	Pennsylvania	United States	15232
500	UPMC-Shadyside Hospital	Pittsburgh	Pennsylvania	United States	15232
501	UPMC Jefferson Regional Radiation Oncology	Pittsburgh	Pennsylvania	United States	15236
502	UPMC-Passavant Hospital	Pittsburgh	Pennsylvania	United States	15237
503	UPMC-Saint Clair Hospital Cancer Center	Pittsburgh	Pennsylvania	United States	15243
504	UPMC Cancer Center at UPMC Northwest	Seneca	Pennsylvania	United States	16346
505	Geisinger Medical Group	State College	Pennsylvania	United States	16801
506	UPMC Uniontown Hospital Radiation Oncology	Uniontown	Pennsylvania	United States	15401
507	UPMC Washington Hospital Radiation Oncology	Washington	Pennsylvania	United States	15301
508	Reading Hospital	West Reading	Pennsylvania	United States	19611
509	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
510	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
511	WellSpan Health-York Cancer Center	York	Pennsylvania	United States	17403
512	WellSpan Health-York Hospital	York	Pennsylvania	United States	17403
513	Women and Infants Hospital	Providence	Rhode Island	United States	02905
514	Medical University of South Carolina	Charleston	South Carolina	United States	29425
515	Greenville Health System Cancer Institute-Easley	Easley	South Carolina	United States	29640
516	Greenville Health System Cancer Institute-Andrews	Greenville	South Carolina	United States	29601
517	Saint Francis Hospital	Greenville	South Carolina	United States	29601
518	Greenville Health System Cancer Institute-Butternut	Greenville	South Carolina	United States	29605
519	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
520	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
521	Saint Francis Cancer Center	Greenville	South Carolina	United States	29607
522	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
523	Greenville Health System Cancer Institute-Greer	Greer	South Carolina	United States	29650
524	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
525	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
526	Memorial Hospital	Chattanooga	Tennessee	United States	37404
527	Pulmonary Medicine Center of Chattanooga-Hixson	Hixson	Tennessee	United States	37343
528	University of Tennessee - Knoxville	Knoxville	Tennessee	United States	37920
529	Memorial GYN Plus	Ooltewah	Tennessee	United States	37363
530	Parkland Memorial Hospital	Dallas	Texas	United States	75235
531	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
532	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
533	UTMB Cancer Center at Victory Lakes	League City	Texas	United States	77573
534	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
535	Fredericksburg Oncology Inc	Fredericksburg	Virginia	United States	22401
536	Carilion Clinic Gynecological Oncology	Roanoke	Virginia	United States	24016
537	Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	United States	98520
538	Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
539	MultiCare Auburn Medical Center	Auburn	Washington	United States	98001
540	Virginia Mason Bainbridge Island Medical Center	Bainbridge Island	Washington	United States	98110
541	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
542	Swedish Cancer Institute-Eastside Oncology Hematology	Bellevue	Washington	United States	98005
543	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
544	Harrison HealthPartners Hematology and Oncology-Bremerton	Bremerton	Washington	United States	98310
545	Harrison Medical Center	Bremerton	Washington	United States	98310
546	Highline Medical Center-Main Campus	Burien	Washington	United States	98166
547	Providence Regional Cancer System-Centralia	Centralia	Washington	United States	98531
548	Swedish Medical Center-Edmonds	Edmonds	Washington	United States	98026
549	Saint Elizabeth Hospital	Enumclaw	Washington	United States	98022
550	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
551	Virginia Mason Federal Way Medical Center	Federal Way	Washington	United States	98002
552	Saint Francis Hospital	Federal Way	Washington	United States	98003
553	Tacoma/Valley Radiation Oncology Centers-Gig Harbor	Gig Harbor	Washington	United States	98332
554	MultiCare Gig Harbor Medical Park	Gig Harbor	Washington	United States	98335
555	Swedish Cancer Institute-Issaquah	Issaquah	Washington	United States	98029
556	Northwest Cancer Clinic	Kennewick	Washington	United States	99336
557	Providence Regional Cancer System-Lacey	Lacey	Washington	United States	98503
558	Saint Clare Hospital	Lakewood	Washington	United States	98499
559	PeaceHealth Saint John Medical Center	Longview	Washington	United States	98632
560	Virginia Mason Lynnwood Medical Center	Lynnwood	Washington	United States	98036
561	Jefferson Healthcare	Port Townsend	Washington	United States	98368
562	Harrison HealthPartners Hematology and Oncology-Poulsbo	Poulsbo	Washington	United States	98370
563	Peninsula Cancer Center	Poulsbo	Washington	United States	98370
564	MultiCare Good Samaritan Hospital	Puyallup	Washington	United States	98372
565	Tacoma/Valley Radiation Oncology Centers-Puyallup	Puyallup	Washington	United States	98372
566	Virginia Mason Medical Center	Seattle	Washington	United States	98101
567	Minor and James Medical PLLC	Seattle	Washington	United States	98104
568	Pacific Gynecology Specialists	Seattle	Washington	United States	98104
569	Swedish Medical Center-Ballard Campus	Seattle	Washington	United States	98107
570	Kaiser Permanente Washington	Seattle	Washington	United States	98112
571	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
572	Providence Regional Cancer System-Shelton	Shelton	Washington	United States	98584
573	Rockwood Clinic Cancer Treatment Center-Valley	Spokane Valley	Washington	United States	99216
574	Rockwood Cancer Treatment Center-DHEC-Downtown	Spokane	Washington	United States	99204
575	Evergreen Hematology and Oncology PS	Spokane	Washington	United States	99218
576	Rockwood North Cancer Treatment Center	Spokane	Washington	United States	99218
577	Tacoma/Valley Radiation Oncology Centers-Jackson Hall	Tacoma	Washington	United States	97405
578	Franciscan Research Center-Northwest Medical Plaza	Tacoma	Washington	United States	98405
579	MultiCare Tacoma General Hospital	Tacoma	Washington	United States	98405
580	Northwest Medical Specialties PLLC	Tacoma	Washington	United States	98405
581	Northwest NCI Community Oncology Research Program	Tacoma	Washington	United States	98405
582	Tacoma/Valley Radiation Oncology Centers-Saint Joe's	Tacoma	Washington	United States	98405
583	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
584	Legacy Salmon Creek Hospital	Vancouver	Washington	United States	98686
585	Providence Saint Mary Regional Cancer Center	Walla Walla	Washington	United States	99362
586	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
587	Providence Regional Cancer System-Yelm	Yelm	Washington	United States	98597
588	Monongalia Hospital	Morgantown	West Virginia	United States	26505
589	Aurora Health Center-Fond du Lac	Fond Du Lac	Wisconsin	United States	54937
590	Aurora Cancer Care-Grafton	Grafton	Wisconsin	United States	53024
591	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
592	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin	United States	53038
593	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
594	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
595	Aurora Bay Area Medical Group-Marinette	Marinette	Wisconsin	United States	54143
596	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
597	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
598	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53233
599	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin	United States	54904
600	Vince Lombardi Cancer Clinic-Sheboygan	Sheboygan	Wisconsin	United States	53081
601	Aurora Medical Center in Summit	Summit	Wisconsin	United States	53066
602	Vince Lombardi Cancer Clinic-Two Rivers	Two Rivers	Wisconsin	United States	54241
603	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
604	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
605	Cheyenne Regional Medical Center-West	Cheyenne	Wyoming	United States	82001
606	Big Horn Basin Cancer Center	Cody	Wyoming	United States	82414
607	Billings Clinic-Cody	Cody	Wyoming	United States	82414
608	Welch Cancer Center	Sheridan	Wyoming	United States	82801
609	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	2650
610	Institut Bergonie Cancer Center	Bordeaux		France	33076
611	Centre Georges-Francois Leclerc	Dijon		France	21079
612	Centre Leon Berard	Lyon		France	69373
613	Centre Catherine de Sienne	Nantes		France	44202
614	University Medical Center Groningen	Groningen		Netherlands	9700 GZ
615	University of Oslo	Oslo		Norway	NO-0316
616	Hospital Clinico San Carlos	Madrid		Spain	28040
617	Addenbrookes Hospital-Medical School	Cambridge	England	United Kingdom	CB2 0QQ
618	University College London Hospital	London	England	United Kingdom	WC1E 6AG
619	Christie Hospital	Manchester	England	United Kingdom	M20 4BX
620	Weston Park Hospital	Sheffield	England	United Kingdom	S10 2SJ
621	Beatson Oncology Center	Glasgow	Scotland	United Kingdom	G12 0YN
622	Institute of Cancer Research - Chelsea	London		United Kingdom	SW7 3RP
623	Hospital Universitario	Caracas		Venezuela	1060

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Martee L Hensley, NRG Oncology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 7, 2017

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT01533207
• Other Study ID Numbers: GOG-0277; NCI-2012-00249; CDR0000724874; IRCI 001; GOG-0277; GOG-0277; GOG-0277; U10CA180868; U10CA027469
• First Posted: Feb 15, 2012
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Leiomyosarcoma; Gemcitabine; Docetaxel; Doxorubicin; Liposomal doxorubicin; Lenograstim

Study Results

Participant Flow

Recruitment Details	This study accrued 38 patients from June 2012 to September, 2016. Study was closed due to accrual futility.

Arm/Group Title	Regimen 1	Regimen II
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles	Observation
Period Title: Overall Study
STARTED	20	18
COMPLETED	20	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Regimen 1	Regimen II	Total
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles	Observation	Total of all reporting groups
Overall Participants	20	18	38
Age, Customized (Count of Participants)
20-29 years	0 0%	0 0%	0 0%
30-39 years	2 10%	0 0%	2 5.3%
40-49 years	4 20%	4 22.2%	8 21.1%
50-59 years	10 50%	7 38.9%	17 44.7%
60-69 years	3 15%	5 27.8%	8 21.1%
70-79 years	1 5%	2 11.1%	3 7.9%
Sex: Female, Male (Count of Participants)
Female	20 100%	18 100%	38 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%	0 0%	2 5.3%
Not Hispanic or Latino	16 80%	17 94.4%	33 86.8%
Unknown or Not Reported	2 10%	1 5.6%	3 7.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 5.6%	1 2.6%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5%	4 22.2%	5 13.2%
White	15 75%	11 61.1%	26 68.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 20%	2 11.1%	6 15.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Death
Description	The duration of time from study entry to time of death or the date of last contact.
Time Frame	Follow-up every 4 months for 3 years, then every 6 months for 2 years.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Regimen 1	Regimen II
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles	Observation
Measure Participants	20	18
Number [Participants]	5 25%	1 5.6%

2. Secondary Outcome

Title	Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time Frame	Approximately 4 years

Outcome Measure Data

Analysis Population Description

eligible and randomized patients

Arm/Group Title	Regimen 1	Regimen II
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles	Observation
Measure Participants	20	18
Number [participants]	10 50%	1 5.6%

3. Secondary Outcome

Title	Number of Participants With Recurrence
Description	The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.
Time Frame	Follow-up every 4 months for 3 years, then every 6 months for 2 years.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Regimen 1	Regimen II
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles	Observation
Measure Participants	20	18
Number [participants]	8 40%	8 44.4%

4. Other Pre-specified Outcome

Title	Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors
Description	Analyses will be carried out using proportional hazards models of both survival and recurrence.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
Arm/Group Title	Regimen 1		Regimen II
Arm/Group Description	Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles		Observation
All Cause Mortality
	Regimen 1		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/20 (25%)		1/18 (5.6%)
Serious Adverse Events
	Regimen 1		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/20 (25%)		0/18 (0%)
Gastrointestinal disorders
Mucositis Oral	1/20 (5%)		0/18 (0%)
Infections and infestations
Wound Infection	1/20 (5%)		0/18 (0%)
Skin Infection	1/20 (5%)		0/18 (0%)
Catheter Related Infection	1/20 (5%)		0/18 (0%)
Injury, poisoning and procedural complications
Vascular Access Complication	1/20 (5%)		0/18 (0%)
Investigations
Neutrophil Count Decreased	1/20 (5%)		0/18 (0%)
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other	1/20 (5%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Regimen 1		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/20 (80%)		12/18 (66.7%)
Blood and lymphatic system disorders
Leukocytosis	1/20 (5%)		0/18 (0%)
Blood And Lymphatic System Disorders - Other	3/20 (15%)		0/18 (0%)
Anemia	13/20 (65%)		1/18 (5.6%)
Cardiac disorders
Atrial Fibrillation	1/20 (5%)		0/18 (0%)
Palpitations	4/20 (20%)		1/18 (5.6%)
Chest Pain - Cardiac	1/20 (5%)		0/18 (0%)
Ear and labyrinth disorders
Hearing Impaired	1/20 (5%)		0/18 (0%)
Ear Pain	1/20 (5%)		0/18 (0%)
Eye disorders
Watering Eyes	2/20 (10%)		0/18 (0%)
Blurred Vision	2/20 (10%)		1/18 (5.6%)
Gastrointestinal disorders
Dysphagia	1/20 (5%)		0/18 (0%)
Dyspepsia	2/20 (10%)		1/18 (5.6%)
Constipation	6/20 (30%)		1/18 (5.6%)
Diarrhea	7/20 (35%)		1/18 (5.6%)
Vomiting	4/20 (20%)		1/18 (5.6%)
Bloating	2/20 (10%)		1/18 (5.6%)
Anal Hemorrhage	0/20 (0%)		1/18 (5.6%)
Abdominal Pain	4/20 (20%)		4/18 (22.2%)
Mucositis Oral	5/20 (25%)		0/18 (0%)
Lower Gastrointestinal Hemorrhage	0/20 (0%)		1/18 (5.6%)
Gastrointestinal Disorders - Other	0/20 (0%)		1/18 (5.6%)
Oral Pain	2/20 (10%)		0/18 (0%)
Nausea	12/20 (60%)		1/18 (5.6%)
Gastroesophageal Reflux Disease	1/20 (5%)		0/18 (0%)
Hemorrhoidal Hemorrhage	0/20 (0%)		1/18 (5.6%)
Toothache	1/20 (5%)		0/18 (0%)
Flatulence	1/20 (5%)		0/18 (0%)
General disorders
General Disorders And Administration Site Conditio	0/20 (0%)		1/18 (5.6%)
Pain	2/20 (10%)		1/18 (5.6%)
Malaise	1/20 (5%)		0/18 (0%)
Non-Cardiac Chest Pain	1/20 (5%)		0/18 (0%)
Edema Limbs	7/20 (35%)		2/18 (11.1%)
Fatigue	14/20 (70%)		5/18 (27.8%)
Fever	6/20 (30%)		0/18 (0%)
Chills	1/20 (5%)		0/18 (0%)
Infusion Related Reaction	2/20 (10%)		0/18 (0%)
Infections and infestations
Infections And Infestations - Other	2/20 (10%)		0/18 (0%)
Upper Respiratory Infection	2/20 (10%)		0/18 (0%)
Tooth Infection	1/20 (5%)		0/18 (0%)
Skin Infection	1/20 (5%)		0/18 (0%)
Sinusitis	1/20 (5%)		1/18 (5.6%)
Lung Infection	1/20 (5%)		0/18 (0%)
Phlebitis Infective	1/20 (5%)		0/18 (0%)
Urinary Tract Infection	2/20 (10%)		0/18 (0%)
Investigations
Weight Gain	1/20 (5%)		0/18 (0%)
Platelet Count Decreased	7/20 (35%)		0/18 (0%)
Creatinine Increased	2/20 (10%)		0/18 (0%)
Neutrophil Count Decreased	8/20 (40%)		0/18 (0%)
White Blood Cell Decreased	7/20 (35%)		0/18 (0%)
Aspartate Aminotransferase Increased	4/20 (20%)		0/18 (0%)
Alkaline Phosphatase Increased	3/20 (15%)		0/18 (0%)
Alanine Aminotransferase Increased	5/20 (25%)		0/18 (0%)
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other	1/20 (5%)		0/18 (0%)
Hypophosphatemia	1/20 (5%)		0/18 (0%)
Hyponatremia	2/20 (10%)		0/18 (0%)
Hypomagnesemia	1/20 (5%)		0/18 (0%)
Hypokalemia	3/20 (15%)		0/18 (0%)
Hypocalcemia	4/20 (20%)		0/18 (0%)
Hypoalbuminemia	4/20 (20%)		0/18 (0%)
Hypernatremia	2/20 (10%)		0/18 (0%)
Hyperglycemia	4/20 (20%)		1/18 (5.6%)
Anorexia	5/20 (25%)		0/18 (0%)
Musculoskeletal and connective tissue disorders
Pain In Extremity	3/20 (15%)		1/18 (5.6%)
Myalgia	3/20 (15%)		1/18 (5.6%)
Generalized Muscle Weakness	1/20 (5%)		0/18 (0%)
Flank Pain	1/20 (5%)		0/18 (0%)
Chest Wall Pain	0/20 (0%)		1/18 (5.6%)
Buttock Pain	0/20 (0%)		1/18 (5.6%)
Bone Pain	2/20 (10%)		0/18 (0%)
Back Pain	0/20 (0%)		1/18 (5.6%)
Arthritis	0/20 (0%)		1/18 (5.6%)
Arthralgia	3/20 (15%)		0/18 (0%)
Nervous system disorders
Nervous System Disorders - Other	1/20 (5%)		0/18 (0%)
Peripheral Sensory Neuropathy	5/20 (25%)		0/18 (0%)
Paresthesia	1/20 (5%)		0/18 (0%)
Headache	4/20 (20%)		3/18 (16.7%)
Dysgeusia	2/20 (10%)		0/18 (0%)
Syncope	1/20 (5%)		0/18 (0%)
Dizziness	3/20 (15%)		1/18 (5.6%)
Akathisia	1/20 (5%)		0/18 (0%)
Psychiatric disorders
Personality Change	1/20 (5%)		0/18 (0%)
Insomnia	4/20 (20%)		1/18 (5.6%)
Depression	3/20 (15%)		2/18 (11.1%)
Anxiety	3/20 (15%)		3/18 (16.7%)
Renal and urinary disorders
Urine Discoloration	1/20 (5%)		0/18 (0%)
Urinary Urgency	0/20 (0%)		1/18 (5.6%)
Urinary Incontinence	2/20 (10%)		1/18 (5.6%)
Urinary Tract Pain	0/20 (0%)		1/18 (5.6%)
Urinary Frequency	1/20 (5%)		1/18 (5.6%)
Proteinuria	1/20 (5%)		0/18 (0%)
Hematuria	1/20 (5%)		0/18 (0%)
Reproductive system and breast disorders
Vaginal Hemorrhage	0/20 (0%)		1/18 (5.6%)
Vaginal Inflammation	1/20 (5%)		0/18 (0%)
Dyspareunia	0/20 (0%)		1/18 (5.6%)
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -	1/20 (5%)		0/18 (0%)
Sore Throat	5/20 (25%)		0/18 (0%)
Postnasal Drip	1/20 (5%)		0/18 (0%)
Pneumonitis	1/20 (5%)		0/18 (0%)
Nasal Congestion	0/20 (0%)		1/18 (5.6%)
Productive Cough	1/20 (5%)		0/18 (0%)
Dyspnea	6/20 (30%)		0/18 (0%)
Cough	3/20 (15%)		1/18 (5.6%)
Allergic Rhinitis	1/20 (5%)		0/18 (0%)
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other	2/20 (10%)		0/18 (0%)
Skin Hyperpigmentation	1/20 (5%)		0/18 (0%)
Scalp Pain	1/20 (5%)		0/18 (0%)
Purpura	1/20 (5%)		0/18 (0%)
Pruritus	0/20 (0%)		1/18 (5.6%)
Rash Maculo-Papular	3/20 (15%)		0/18 (0%)
Dry Skin	1/20 (5%)		0/18 (0%)
Alopecia	11/20 (55%)		1/18 (5.6%)
Surgical and medical procedures
Surgical And Medical Procedures - Other	1/20 (5%)		0/18 (0%)
Vascular disorders
Thromboembolic Event	3/20 (15%)		0/18 (0%)
Superficial Thrombophlebitis	1/20 (5%)		0/18 (0%)
Hypertension	2/20 (10%)		2/18 (11.1%)
Hot Flashes	4/20 (20%)		4/18 (22.2%)
Flushing	1/20 (5%)		1/18 (5.6%)

Limitations/Caveats

The study was closed early due to slow participant accrual.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.