Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00112489
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 55
• Locations: 110
• Arm: 1
• Patients Per Site: 0.5

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: carboplatin; Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

• Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.

• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day

1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Taxol-Carbo Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy	Drug: carboplatin; Drug: paclitaxel

Outcome Measures

Primary Outcome Measures

1. Nature and Degree of Toxicity [During study treatment and up to 30 days after stopping study treatment]

   Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0

2. Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response [Response was measured every other cycle (q 6 weeks) until disease progression is documented.]

   Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)

• Stage III or IV disease

• Persistent or recurrent disease

• Documented disease progression

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression

• Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• No sensory or motor neuropathy > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy for uterine sarcoma

Endocrine therapy

• At least 1 week since prior hormonal therapy for uterine sarcoma

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• Recovered from all prior therapy

• No prior anticancer therapy that would preclude study therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama	United States	35294
2	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
3	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut	United States	06050
4	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
5	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
6	St. Vincent's Medical Center	Jacksonville	Florida	United States	32204
7	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
8	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
9	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
10	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
11	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
12	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
13	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
14	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
15	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
16	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
17	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
18	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
19	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
20	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
21	Woman's Hospital	Baton Rouge	Louisiana	United States	70815
22	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
23	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
24	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
25	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
26	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
27	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
28	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
29	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
30	Hurley Medical Center	Flint	Michigan	United States	48503
31	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
32	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
33	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
34	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
35	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
36	Holland Community Hospital	Holland	Michigan	United States	49423
37	Foote Memorial Hospital	Jackson	Michigan	United States	49201
38	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
39	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
40	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
41	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
42	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
43	Hackley Hospital	Muskegon	Michigan	United States	49442
44	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
45	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
46	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
47	Munson Medical Center	Traverse City	Michigan	United States	49684
48	St. John Macomb Hospital	Warren	Michigan	United States	48093
49	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
50	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
51	Saint Mary's Health Center	Saint Louis	Missouri	United States	63117
52	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
53	St. John's Regional Health Center	Springfield	Missouri	United States	65804
54	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
55	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
56	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754-0397
57	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
58	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
59	Mount Sinai Medical Center	New York	New York	United States	10029
60	Hope A Women's Cancer Center	Asheville	North Carolina	United States	28801
61	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
62	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
63	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
64	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
65	Piedmont Hematology-Oncology Associates	Winston-Salem	North Carolina	United States	27103
66	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
67	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
68	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
69	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
70	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
71	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
72	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
73	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
74	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
75	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
76	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
77	Lake/University Ireland Cancer Center	Mentor	Ohio	United States	44060
78	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
79	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma	United States	74104
80	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
81	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
82	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
83	Fox Chase Cancer Center CCOP Research Base	Philadelphia	Pennsylvania	United States	19140
84	Women and Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
85	Black Hills Obstetrics & Gynecology LLP	Rapid City	South Dakota	United States	57701
86	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
87	Hall and Martin, M.Ds., PC	Knoxville	Tennessee	United States	37920
88	Harrington Cancer Center	Amarillo	Texas	United States	79106
89	Parkland Memorial Hospital	Dallas	Texas	United States	75235
90	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
91	University of Texas Medical Branch	Galveston	Texas	United States	77555-0361
92	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
93	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0037
94	Carilion Gynecologic Oncology Associates	Roanoke	Virginia	United States	24014
95	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
96	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
97	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
98	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
99	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
100	Iwate Medical University Hospital	Morioka	Iwate	Japan	020-8505
101	Kagoshima City Hospital	Kagoshima City, Kagoshima		Japan	892-8580
102	Kobe Medical Center	Kobe		Japan	654-0155
103	National Hospital Organization - Medical Center of Kure	Kure		Japan	737
104	Shikoku Cancer Center	Matsuyama		Japan	791-0288
105	National Kyushu Cancer Center	Minami-ku		Japan	811 1395
106	Kinki University School of Medicine	Osaka, Osaka		Japan	589 8511
107	Hokkaido University Hospital	Sapporo		Japan	060-8648
108	Tohoku University Graduate School of Medicine	Sendai		Japan
109	Keio University School of Medicine	Shinjuku-ku		Japan	160-8582
110	Tottori University Hospital	Tottori		Japan	680-8550

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Matthew A. Powell, MD, Washington University Siteman Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00112489
• Other Study ID Numbers: CDR0000432956; GOG-0232B
• First Posted: Jun 3, 2005
• Last Update Posted: Sep 25, 2018
• Last Verified: Apr 1, 2014

• Keywords provided by Gynecologic Oncology Group: recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; uterine carcinosarcoma
• Additional relevant MeSH terms: Sarcoma; Carcinosarcoma; Paclitaxel; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Paclitaxel Followed by Carboplatin
Arm/Group Description	Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
STARTED	55
COMPLETED	15
NOT COMPLETED	40

Baseline Characteristics

Arm/Group Title	Paclitaxel Followed by Carboplatin
Arm/Group Description	Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
Overall Participants	46
Age, Customized (years) [Mean (Standard Deviation) ]
Age at Study Entry	65.5 (11.6)
Sex: Female, Male (Count of Participants)
Female	46 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Nature and Degree of Toxicity
Description	Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Time Frame	During study treatment and up to 30 days after stopping study treatment

Outcome Measure Data

Analysis Population Description

Eligible and Evaluable patients

Arm/Group Title	Grade 0	Grade 1 (CTCAE v 3.0)	Grade 2 (CTCAE v 3.0)	Grade 3 (CTCAE v 3.0)	Grade 4 (CTCAE v 3.0)	Grade 5 (CTCAE v.3.0)
Arm/Group Description	Number of patients who did not experience the specified AE	Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Measure Participants	46	46	46	46	46	46
Leukopenia	2 4.3%	4 NaN	20 NaN	19 NaN	1 NaN	0 NaN
Neutropenia	1 2.2%	3 NaN	3 NaN	19 NaN	20 NaN	0 NaN
Thrombocytopenia	17 37%	19 NaN	5 NaN	3 NaN	2 NaN	0 NaN
Anemia	4 8.7%	10 NaN	27 NaN	3 NaN	2 NaN	0 NaN
Other hematologic	43 93.5%	0 NaN	1 NaN	2 NaN	0 NaN	0 NaN
Allergy	40 87%	3 NaN	0 NaN	3 NaN	0 NaN	0 NaN
Auditory	43 93.5%	0 NaN	2 NaN	1 NaN	0 NaN	0 NaN
Cardiovascular	39 84.8%	3 NaN	2 NaN	1 NaN	1 NaN	0 NaN
Coagulation	45 97.8%	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Constitutional	33 71.7%	8 NaN	4 NaN	1 NaN	0 NaN	0 NaN
Fatigue	9 19.6%	14 NaN	19 NaN	4 NaN	0 NaN	0 NaN
Alopecia	8 17.4%	7 NaN	31 NaN	0 NaN	0 NaN	0 NaN
Dermatologic	36 78.3%	8 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Endocrine	44 95.7%	2 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Gastrointestinal	18 39.1%	12 NaN	14 NaN	2 NaN	0 NaN	0 NaN
Nausea	17 37%	20 NaN	8 NaN	1 NaN	0 NaN	0 NaN
Vomiting	35 76.1%	7 NaN	3 NaN	1 NaN	0 NaN	0 NaN
Diarrhea	35 76.1%	8 NaN	2 NaN	1 NaN	0 NaN	0 NaN
Stomatitis	35 76.1%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Genitourinary/renal	45 97.8%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Hemorrhage	43 93.5%	1 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Hepatic	45 97.8%	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Febrile neutropenia	45 97.8%	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Metabolic	23 50%	18 NaN	4 NaN	1 NaN	0 NaN	0 NaN
Creatinine	44 95.7%	2 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Musculoskeletal	41 89.1%	2 NaN	2 NaN	1 NaN	0 NaN	0 NaN
Neurologic	40 87%	0 NaN	4 NaN	2 NaN	0 NaN	0 NaN
Neuromotor	44 95.7%	0 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Sensory neuropathy	14 30.4%	15 NaN	12 NaN	5 NaN	0 NaN	0 NaN
Ocular/visual	43 93.5%	2 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Pain	35 76.1%	3 NaN	6 NaN	0 NaN	2 NaN	0 NaN
Myalgia	35 76.1%	3 NaN	7 NaN	1 NaN	0 NaN	0 NaN
Arthralgia	36 78.3%	4 NaN	6 NaN	0 NaN	0 NaN	0 NaN
Pulmonary	37 80.4%	5 NaN	2 NaN	2 NaN	0 NaN	0 NaN

2. Primary Outcome

Title	Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Description	Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time Frame	Response was measured every other cycle (q 6 weeks) until disease progression is documented.

Outcome Measure Data

Analysis Population Description

Total eligible and treated participants

Arm/Group Title	Paclitaxel Followed by Carboplatin
Arm/Group Description	Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
Measure Participants	46
Complete Response	6 13%
Partial Response	19 41.3%
Stable Disease	11 23.9%
Disease Progression	6 13%
Indeterminate	4 8.7%

Adverse Events

Time Frame	During active treatment and up to 30 days after stopping the study treatment.
Adverse Event Reporting Description	Treated & eligible patients. Due to the methods in which Adverse Events(AEs) were collected &/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs & non-serious AEs. Other AEs are Grade 2 or worse & are restricted to those thought to be treatment related.
Arm/Group Title	Paclitaxel Followed by Carboplatin
Arm/Group Description	Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
All Cause Mortality
	Paclitaxel Followed by Carboplatin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel Followed by Carboplatin
	Affected / at Risk (%)	# Events
Total	11/46 (23.9%)
Blood and lymphatic system disorders
Leukocytes	1/46 (2.2%)
Hemoglobin	1/46 (2.2%)
Neutrophils	2/46 (4.3%)
Cardiac disorders
Cardiac ischemia/infarction	1/46 (2.2%)
S/n arrhythmia: atrial fibrillation	1/46 (2.2%)
Supraventricular tachycardia	1/46 (2.2%)
Hypotension	1/46 (2.2%)
Gastrointestinal disorders
Nausea	1/46 (2.2%)
Vomiting	2/46 (4.3%)
Dehydration	1/46 (2.2%)
Distention	1/46 (2.2%)
Obstruction, gi - colon	1/46 (2.2%)
Gastrointestinal - other	1/46 (2.2%)
General disorders
Fatigue	1/46 (2.2%)
Death, no ctcae term - death nos	1/46 (2.2%)
Death, no ctcae term - disease progression	1/46 (2.2%)
Pain: abdominal pain nos	1/46 (2.2%)
Infections and infestations
Inf w/nml or gr 1 or 2 anc: urinary tract	1/46 (2.2%)
Inf unknown anc: bladder (urinary)	1/46 (2.2%)
Inf unknown anc: urinary tract nos	1/46 (2.2%)
Metabolism and nutrition disorders
Bilirubin	1/46 (2.2%)
Musculoskeletal and connective tissue disorders
Muscle weakness - extremity-lower	1/46 (2.2%)
muscle weakness - extremity-upper	1/46 (2.2%)
Nervous system disorders
Dizziness	1/46 (2.2%)
Confusion	1/46 (2.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/46 (4.3%)
Pleural effusion	1/46 (2.2%)
Hypoxia	1/46 (2.2%)
Vascular disorders
PTT	1/46 (2.2%)
Thrombosis/thrombus/embolism	1/46 (2.2%)
Other (Not Including Serious) Adverse Events
	Paclitaxel Followed by Carboplatin
	Affected / at Risk (%)	# Events
Total	46/46 (100%)
Blood and lymphatic system disorders
Leukopenia	40/46 (87%)
Neutropenia	43/46 (93.5%)
Thrombocytopenia	10/46 (21.7%)
Anemia	32/46 (69.6%)
Other Hematologic	3/46 (6.5%)
Hemorrhage	2/46 (4.3%)
Febrile Neutropenia	1/46 (2.2%)
Cardiac disorders
Cardiovascular	4/46 (8.7%)
Ear and labyrinth disorders
Auditory	3/46 (6.5%)
Eye disorders
Ocular/Visual	1/46 (2.2%)
Gastrointestinal disorders
Other, Gastrointestinal	16/46 (34.8%)
Nausea	9/46 (19.6%)
Vomiting	4/46 (8.7%)
Diarrhea	3/46 (6.5%)
General disorders
Constitutional	5/46 (10.9%)
Fatigue	24/46 (52.2%)
Death	2/46 (4.3%)
Pain	8/46 (17.4%)
Immune system disorders
Allergy	3/46 (6.5%)
Metabolism and nutrition disorders
Metabolic	6/46 (13%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	3/46 (6.5%)
Myalgia	8/46 (17.4%)
Arthralgia	6/46 (13%)
Nervous system disorders
Neurologic	6/46 (13%)
Neuromotor	2/46 (4.3%)
Sensory Neuropathy	18/46 (39.1%)
Respiratory, thoracic and mediastinal disorders
Pulmonary	4/46 (8.7%)
Skin and subcutaneous tissue disorders
Alopecia	31/46 (67.4%)
Dermatologic	2/46 (4.3%)
Vascular disorders
Coagulation	1/46 (2.2%)

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.