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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002913 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: cisplatin Drug: filgrastim Drug: paclitaxel Drug: topotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES |
Estimated Enrollment: | 30 |
Study Start Date: | December 1996 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose escalation study of topotecan.
Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed as clinically indicated.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed epithelial ovarian carcinoma
The following histologies are eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Iowa | |
Holden Comprehensive Cancer Center | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Vermont | |
Fletcher Allen Health Care - Medical Center Campus | |
Burlington, Vermont, United States, 05401 |
Study Chair: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000065286, GOG-9602 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002913 |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV 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 |
Cystadenocarcinoma, Serous Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Carcinoma, Endometrioid Carcinoma Genital Diseases, Female Cisplatin Paclitaxel Endocrinopathy Topotecan Adenocarcinoma Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |