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| Sponsors and Collaborators: |
AGO Ovarian Cancer Study Group European Organization for Research and Treatment of Cancer National Cancer Institute of Canada |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006453 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy |
| Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.
Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 74 Study Locations| Study Chair: | Jacobus Pfisterer, MD | University Hospital Schleswig-Holstein - Kiel Campus |
| Study Chair: | Angel J. Lacave, MD, PhD | Hospital Universitario Central de Asturias |
| Study Chair: | Marie Plante, MD | Centre Hospitalier Universitaire de Quebec |
More Information
| Study ID Numbers: | CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601 |
| Study First Received: | November 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006453 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer |
|
Antimetabolites Ovarian Neoplasms Immunologic Factors Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases Ovarian Epithelial Cancer |
Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Genital Diseases, Female Radiation-Sensitizing Agents Ovarian Cancer Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses |
Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents |