S9912 Combination Chemo in Stage III Ovarian Cancer,

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003896
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 68
• Locations: 104
• Arm: 1
• Duration (Months): 101
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer	Drug: cisplatin; Drug: liposomal doxorubicin; Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

• Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.

• Determine the feasibility of and toxic effects associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
• Study Start Date: Sep 1, 1999
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel/cisplatin/Liposomal Doxorubicin paclitaxel, cisplatin and liposomal doxorubicin	Drug: cisplatin; Other Names: platinol ; Drug: liposomal doxorubicin; Other Names: pegylated liposomal doxorubicin hydrochloride doxil ; Drug: paclitaxel; Other Names: taxol

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.]

   From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.

2. Overall Survival [Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.]

   from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact

Secondary Outcome Measures

1. Adverse Events [Weekly during 6 weeks of protocol treatment]

   Only adverse events that are possibly, probably or definitely related to study drug are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

• Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis

• No tumors of borderline or low malignant potential only

• Mixed Mullerian tumors allowed

• Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter

• Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• SWOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• SGOT or SGPT ≤ 2 times ULN

Renal:

• Creatinine clearance ≥ 50 mL/min

Cardiovascular:

• No congestive heart failure

• No cardiac arrhythmia

• No myocardial infarction or unstable angina within the past 6 months

• Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No active or uncontrolled infection

• No concurrent fever

• No grade 2 or greater sensory neuropathy

• No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection

• No erythema or tenderness of abdominal incision or port site suggestive of underlying infection

• No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for ovarian cancer

Chemotherapy:

• No prior chemotherapy for ovarian cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic radiotherapy for ovarian cancer

Surgery:

• See Disease Characteristics

• Recovered from all reversible surgery-related toxic effects

Other:

• No other concurrent antitumor treatment

• No concurrent antibiotics for infection of undetermined etiology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
2	University of California Davis Cancer Center	Davis	California	United States	95616
3	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
4	Saint Rose Hospital	Hayward	California	United States	94545
5	Valley Memorial Hospital	Livermore	California	United States	94550
6	Highland General Hospital	Oakland	California	United States	94602
7	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
8	Summit Medical Center	Oakland	California	United States	94609
9	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California	United States	94806
10	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
11	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho	United States	83712
12	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
13	Good Samaritan Regional Health Center	Mt. Vernon	Illinois	United States	62864
14	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
15	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
16	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
17	Cancer Center of Kansas - Kingman	Kingman	Kansas	United States	67068
18	Southwest Medical Center	Liberal	Kansas	United States	67901
19	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
20	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
21	Pratt Cancer Center of Kansas	Pratt	Kansas	United States	67124
22	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67042
23	Salina Regional Health Center	Salina	Kansas	United States	67401
24	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
25	Associates in Womens Health	Wichita	Kansas	United States	67203
26	Cancer Center of Kansas, P.A.	Wichita	Kansas	United States	67208
27	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
28	CCOP - Wichita	Wichita	Kansas	United States	67214
29	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
30	Wesley Medical Center	Wichita	Kansas	United States	67214
31	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
32	Cancer Care Center at Battle Creek Health System	Battle Creek	Michigan	United States	49017
33	Bay Regional Medical Center	Bay City	Michigan	United States	48708
34	Mecosta County General Hospital	Big Rapids	Michigan	United States	49307
35	Breslin Cancer Center at Ingham Regional Medical Center	East Lansing	Michigan	United States	48824-1313
36	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
37	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan	United States	49503
38	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan	United States	49503
39	Metropolitan Hospital	Grand Rapids	Michigan	United States	49506
40	Spectrum Health Hospital - Blodgett Campus	Grand Rapids	Michigan	United States	49506
41	Holland Community Hospital	Holland	Michigan	United States	49423
42	Hackley Hospital	Muskegon	Michigan	United States	49443
43	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
44	Mercy Hospital	Port Huron	Michigan	United States	48060
45	Munson Medical Center	Traverse City	Michigan	United States	49684
46	St. Francis Medical Center	Cape Girardeau	Missouri	United States	63701
47	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri	United States	63701
48	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri	United States	63141
49	David C. Pratt Cancer Center at St. John's Mercy	St. Louis	Missouri	United States	63141
50	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
51	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59101
52	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
53	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
54	St. Vincent Healthcare	Billings	Montana	United States	59101
55	Deaconess Billings Clinic Cancer Center	Billings	Montana	United States	59107
56	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
57	Internal Medicine Associates of Bozeman	Bozeman	Montana	United States	59715
58	St. James Community Hospital	Butte	Montana	United States	59701
59	Big Sky Oncology	Great Falls	Montana	United States	59405
60	Great Falls Clinic	Great Falls	Montana	United States	59405
61	Sletten Regional Cancer Institute	Great Falls	Montana	United States	59405
62	St. Peter's Hospital	Helena	Montana	United States	59601
63	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
64	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
65	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
66	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
67	Community Medical Center	Missoula	Montana	United States	59801
68	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59802
69	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59802
70	Judy L. Schmidt, MD, FACP, P. C.	Missoula	Montana	United States	59804
71	Good Samaritan Health Systems	Kearney	Nebraska	United States	68847
72	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
73	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
74	MedCentral - Mansfield Hospital	Mansfield	Ohio	United States	44903
75	Salem Hospital Regional Cancer Center	Salem	Oregon	United States	97309
76	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina	United States	29621
77	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
78	Harrington Cancer Center	Amarillo	Texas	United States	79106
79	Doctor's Hospital of Laredo	Laredo	Texas	United States	78041
80	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
81	Danville Regional Medical Center	Danville	Virginia	United States	24541
82	Auburn Regional Center for Cancer Care	Auburn	Washington	United States	98002
83	St. Joseph Hospital Community Cancer Center	Bellingham	Washington	United States	98225
84	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
85	Providence Hospital	Centralia	Washington	United States	98531
86	St. Francis Hospital	Federal Way	Washington	United States	98003
87	Cancer Care Center at Skagit Valley Hospital	Mt. Vernon	Washington	United States	98273
88	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	95806
89	Capital Medical Center	Olympia	Washington	United States	98507
90	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
91	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
92	Group Health Central Hospital	Seattle	Washington	United States	98104
93	Harborview Medical Center	Seattle	Washington	United States	98104
94	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98114
95	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
96	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
97	Allenmore Hospital	Tacoma	Washington	United States	98405
98	CCOP - Northwest	Tacoma	Washington	United States	98405
99	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington	United States	98405
100	St. Clare Hospital	Tacoma	Washington	United States	98499
101	Central Washington Hospital	Wenatchee	Washington	United States	98801
102	Wenatchee Valley Clinic	Wenatchee	Washington	United States	98801
103	Camden-Clark Memorial Hospital	Parkersburg	West Virginia	United States	26101
104	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Harriet O. Smith, MD, University of New Mexico Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00003896
• Other Study ID Numbers: CDR0000067066; S9912; U10CA032102
• First Posted: Jan 27, 2003
• Last Update Posted: Jan 4, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Southwest Oncology Group: stage III ovarian epithelial cancer; peritoneal cavity cancer; fallopian tube cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Paclitaxel; Doxorubicin; Liposomal doxorubicin

Study Results

Participant Flow

Arm/Group Title	Paclitaxel/CDDP/Lipo Doxorubicin
Arm/Group Description	intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
Period Title: Overall Study
STARTED	68
Eligible	63
COMPLETED	39
NOT COMPLETED	29

Baseline Characteristics

Arm/Group Title	Paclitaxel/CDDP/Lipo Doxorubicin
Arm/Group Description	intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
Overall Participants	63
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	63 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 7.9%
Not Hispanic or Latino	58 92.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 4.8%
Asian	1 1.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	59 93.7%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Description	From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Time Frame	Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.

Outcome Measure Data

Analysis Population Description

Eligible patients who began the treatment intervention

Arm/Group Title	Paclitaxel/CDDP/Lipo Doxorubicin
Arm/Group Description	intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
Measure Participants	63
Median (95% Confidence Interval) [months]	25

2. Primary Outcome

Title	Overall Survival
Description	from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
Time Frame	Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.

Outcome Measure Data

Analysis Population Description

All eligible patients who began the treatment intervention.

Arm/Group Title	Paclitaxel/CDDP/Lipo Doxorubicin
Arm/Group Description	intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
Measure Participants	63
Median (95% Confidence Interval) [months]	51

3. Secondary Outcome

Title	Adverse Events
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Weekly during 6 weeks of protocol treatment

Outcome Measure Data

Analysis Population Description

Paclitaxel/CDDP/Liposomal doxorubicin

Arm/Group Title	Paclitaxel/CDDP/Liposomal Doxorubicin
Arm/Group Description
Measure Participants	61
Abdominal pain/cramping	7 11.1%
Allergic reaction	2 3.2%
Anemia	5 7.9%
Anorexia	5 7.9%
Ataxia (incoordination)	1 1.6%
Bone pain	1 1.6%
Cardiac ischemia/infarction	1 1.6%
Catheter related infection	4 6.3%
Chest pain,not cardio or pleur	1 1.6%
Confusion	1 1.6%
Constipation/bowel obstruction	5 7.9%
Creatinine increase	1 1.6%
Dehydration	5 7.9%
Diarrhea without colostomy	4 6.3%
Dizziness/light headedness	1 1.6%
Dyspepsia/heartburn	1 1.6%
Dyspnea	2 3.2%
Esophagitis/dysphagia	1 1.6%
Fatigue/malaise/lethargy	10 15.9%
Febrile neutropenia	6 9.5%
GI Mucositis, NOS	1 1.6%
GU fistula	1 1.6%
Hand-foot skin reaction	3 4.8%
Headache	1 1.6%
Hyperglycemia	2 3.2%
Hypertension	1 1.6%
Hypoalbuminemia	1 1.6%
Hypocalcemia	1 1.6%
Hypokalemia	4 6.3%
Hypomagnesemia	2 3.2%
Hypotension	1 1.6%
Ileus	2 3.2%
Infection w/o 3-4 neutropenia	5 7.9%
Infection with 3-4 neutropenia	4 6.3%
Infection, unk ANC	2 3.2%
Insomnia	1 1.6%
Intestinal fistula	1 1.6%
Leukopenia	32 50.8%
Lymphopenia	16 25.4%
Metabolic-other	1 1.6%
Myalgia	1 1.6%
Nausea	14 22.2%
Neutropenia/granulocytopenia	35 55.6%
PRBC transfusion	5 7.9%
Platelet transfusion	1 1.6%
Pneumonitis/infiltrates	1 1.6%
Renal failure	1 1.6%
Respiratory infect w/ neutrop	2 3.2%
SGOT (AST) increase	1 1.6%
SGPT (ALT) increase	1 1.6%
Somnolence/consciousness loss	1 1.6%
Stomatitis/pharyngitis	4 6.3%
Thrombocytopenia	5 7.9%
Thrombosis/embolism	4 6.3%
Urinary tr infect w/o neutrop	2 3.2%
Vomiting	9 14.3%
Weakness (motor neuropathy)	3 4.8%
Weight loss	1 1.6%

Adverse Events

Time Frame	Weekly until the end of 6 weeks of protocol treatment.
Arm/Group Title	Paclitaxel/CDDP/Liposomal Doxorubicin
Arm/Group Description
All Cause Mortality
	Paclitaxel/CDDP/Liposomal Doxorubicin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel/CDDP/Liposomal Doxorubicin
	Affected / at Risk (%)	# Events
Total	2/61 (3.3%)
Gastrointestinal disorders
GI Mucositis, NOS	1/61 (1.6%)
Infections and infestations
Infection with 3-4 neutropenia	1/61 (1.6%)
Infection, unk ANC	1/61 (1.6%)
Investigations
Leukopenia	1/61 (1.6%)
Metabolism and nutrition disorders
Dehydration	1/61 (1.6%)
Other (Not Including Serious) Adverse Events
	Paclitaxel/CDDP/Liposomal Doxorubicin
	Affected / at Risk (%)	# Events
Total	60/61 (98.4%)
Blood and lymphatic system disorders
Anemia	43/61 (70.5%)
Febrile neutropenia	6/61 (9.8%)
PRBC transfusion	5/61 (8.2%)
Cardiac disorders
Sinus tachycardia	4/61 (6.6%)
Ear and labyrinth disorders
Inner ear-hearing loss	4/61 (6.6%)
Gastrointestinal disorders
Abdominal pain/cramping	38/61 (62.3%)
Constipation/bowel obstruction	25/61 (41%)
Diarrhea without colostomy	20/61 (32.8%)
Dyspepsia/heartburn	5/61 (8.2%)
Esophagitis/dysphagia	7/61 (11.5%)
Nausea	45/61 (73.8%)
Stomatitis/pharyngitis	24/61 (39.3%)
Vomiting	32/61 (52.5%)
General disorders
Edema	4/61 (6.6%)
Fatigue/malaise/lethargy	38/61 (62.3%)
Fever without neutropenia	5/61 (8.2%)
Pain-other	7/61 (11.5%)
Immune system disorders
Allergic reaction	5/61 (8.2%)
Infections and infestations
Infection w/o 3-4 neutropenia	7/61 (11.5%)
Injury, poisoning and procedural complications
Catheter related infection	7/61 (11.5%)
Local injection site reaction	6/61 (9.8%)
Investigations
Leukopenia	51/61 (83.6%)
Lymphopenia	32/61 (52.5%)
Neutropenia/granulocytopenia	48/61 (78.7%)
SGOT (AST) increase	5/61 (8.2%)
Thrombocytopenia	21/61 (34.4%)
Weight loss	24/61 (39.3%)
Metabolism and nutrition disorders
Anorexia	25/61 (41%)
Dehydration	11/61 (18%)
Hyperglycemia	11/61 (18%)
Hypokalemia	8/61 (13.1%)
Hypomagnesemia	7/61 (11.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/61 (8.2%)
Chest pain,not cardio or pleur	7/61 (11.5%)
Myalgia	10/61 (16.4%)
Nervous system disorders
Dizziness/light headedness	7/61 (11.5%)
Headache	8/61 (13.1%)
Sensory neuropathy	23/61 (37.7%)
Taste disturbance	11/61 (18%)
Weakness (motor neuropathy)	6/61 (9.8%)
Psychiatric disorders
Depression	8/61 (13.1%)
Insomnia	7/61 (11.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	9/61 (14.8%)
Pneumonitis/infiltrates	4/61 (6.6%)
Skin and subcutaneous tissue disorders
Alopecia	39/61 (63.9%)
Hand-foot skin reaction	14/61 (23%)
Rash/desquamation	17/61 (27.9%)
Vascular disorders
Flushing	4/61 (6.6%)
Hypotension	6/61 (9.8%)
Thrombosis/embolism	4/61 (6.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.