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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group Cancer and Leukemia Group B |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002819 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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: | November 1996 |
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.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Hide Study Locations| United States, Alabama | |
| Veterans Affairs Medical Center - Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| University of Illinois at Chicago Health Sciences Center | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Chicago (Lakeside) | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| Veterans Affairs Medical Center - Togus | |
| Togus, Maine, United States, 04330 | |
| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13210 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Pennsylvania | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| Veterans Affairs Medical Center - Nashville | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Vermont | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Veterans Affairs Medical Center - White River Junction | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Veterans Affairs Medical Center - Richmond | |
| Richmond, Virginia, United States, 23249 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Chair: | William P. McGuire, MD | Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
| Study Chair: | Kenneth B. Miller, MD | Tufts Medical Center |
| Study Chair: | Patrick J. Stiff, MD | Loyola University |
| Study Chair: | Stephen L. Graziano, MD | State University of New York - Upstate Medical University |
More Information
| Study ID Numbers: | CDR0000064983, GOG-164, CLB-9791, E-G0164, SWOG-G0164 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002819 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer recurrent ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma Brenner tumor |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Alkylating Agents Endocrine Gland Neoplasms |
Ovarian Neoplasms Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Peripheral Nervous System Agents Mitoxantrone |
