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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002913 |
Purpose
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 |
|---|---|---|
|
Ovarian Cancer |
Biological: filgrastim Drug: cisplatin 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000065286, GOG-9602 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002913 History of Changes |
| 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 Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Ovarian Epithelial Cancer Carcinoma, Endometrioid Carcinoma |
Genital Diseases, Female Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Topotecan Adenocarcinoma Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
|
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 Endocrine Gland Neoplasms Ovarian Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Topotecan Antineoplastic Agents, Phytogenic |