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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00011986 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: topotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma |
Study Start Date: | January 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery:
Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months.
PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
The following are ineligible:
Prior breast cancer allowed provided the following are true:
Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:
Endocrine therapy:
Radiotherapy:
Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:
Surgery:
Study Chair: | Michael A. Bookman, MD | Fox Chase Cancer Center |
Investigator: | William P. McGuire, MD | Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
Study Chair: | Amy D. Tiersten, MD | Herbert Irving Comprehensive Cancer Center |
Study Chair: | Helen Pearce, PhD | Medical Research Council |
Study ID Numbers: | CDR0000068467, GOG-0182, SWOG-G0182, MRC-ICON5, ECOG-G0182 |
Study First Received: | March 3, 2001 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00011986 |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Doxorubicin |
Carcinoma Genital Diseases, Female Digestive System Diseases Paclitaxel Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Topotecan Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |