Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00002819

Collaborator

National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other), Southwest Oncology Group (Other), Cancer and Leukemia Group B (Other)

Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: carboplatin Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase 3

Detailed Description

OBJECTIVES: I. Compare progression-free and overall survival of patients with drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare selected health-related aspects of quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and disease state at reassessment laparotomy. Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4, and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5 assessments regardless of disease progression.

PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY

Study Start Date :

Nov 1, 1996

Actual Primary Completion Date :

Feb 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal) or stage IV clinically reassessed after induction chemotherapy For stage III surgical reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery AND No more than 6 weeks between reassessment surgery and randomization Patients treated on protocol GOG-158 are eligible At least a partial response to chemotherapy as defined as: Microscopic disease documented at reassessment surgery for patients optimally debulked (disease no greater than 1 cm) after primary surgery Suboptimally debulked disease (greater than 1 cm) after primary surgery and 1 of the following: Negative reassessment laparotomy Only microscopic disease at reassessment surgery Gross residual disease no greater than 1 cm at reassessment surgery prior to debulking Clinical complete response to induction chemotherapy including: - suboptimal disease Stage III or IV AND - either an abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal limits following induction chemotherapy

PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic:

Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic:

Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior anthracyclines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama	United States	35233
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94115-0128
4	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
7	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
8	Sylvester Cancer Center, University of Miami	Miami	Florida	United States	33136
9	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
10	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611
11	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois	United States	60611
12	University of Illinois at Chicago Health Sciences Center	Chicago	Illinois	United States	60612
13	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
14	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
15	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
16	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
17	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
18	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
19	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
20	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
21	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
22	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
23	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
24	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
25	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
26	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
27	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
28	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
29	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
30	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
31	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
32	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
33	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
34	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
35	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
36	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
37	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
38	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
39	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
40	North Shore University Hospital	Manhasset	New York	United States	11030
41	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
42	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
43	Mount Sinai Medical Center, NY	New York	New York	United States	10029
44	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13210
45	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
46	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
47	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
48	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
49	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
50	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
51	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
52	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
53	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
54	Rhode Island Hospital	Providence	Rhode Island	United States	02903
55	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
56	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
57	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38163
58	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
59	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
60	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
61	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
62	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
63	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
64	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449

Sponsors and Collaborators

Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Cancer and Leukemia Group B

Investigators

Study Chair: William P. McGuire, MD, Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Study Chair: Kenneth B. Miller, MD, Tufts Medical Center Cancer Center
Study Chair: Patrick J. Stiff, MD, Loyola University
Study Chair: Stephen L. Graziano, MD, State University of New York - Upstate Medical University