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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006028 |
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.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer |
| Study Start Date: | January 2001 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
Bidimensionally measurable disease by physical examination or medical imaging techniques
Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
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 31 Study Locations| Study Chair: | Cheryl A. Brewer, MD | University of Illinois College of Medicine at Peoria |
More Information
| Study ID Numbers: | CDR0000068041, GOG-0126L |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006028 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer peritoneal cavity cancer |
|
Antimetabolites Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Cisplatin Peritoneal Diseases Ovarian Cancer Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Ovarian Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Ovarian Epithelial Cancer Antiviral Agents Immunosuppressive Agents Recurrence Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Therapeutic Uses Peritoneal Diseases |
Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Adnexal Diseases Neoplasms Digestive System Diseases Radiation-Sensitizing Agents |