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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003382 |
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 I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.
Condition | Intervention | Phase |
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: filgrastim Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride |
Phase I |
MedlinePlus related topics: | Cancer Ovarian Cancer |
ChemIDplus related topics: | Filgrastim Gemcitabine hydrochloride Gemcitabine Topotecan hydrochloride Topotecan |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube |
Study Start Date: | May 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4. Some patients receive filgrastim (G-CSF) subcutaneously on days 9-14. Treatment repeats every 28 days for up to 5-10 courses.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (DLT). Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT.
Patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |||||
Chao Family Comprehensive Cancer Center | |||||
Orange, California, United States, 92868 | |||||
Community Hospital of Los Gatos | |||||
Los Gatos, California, United States, 95032 | |||||
Women's Cancer Center | |||||
Palo Alto, California, United States, 94304 | |||||
United States, Illinois | |||||
University of Chicago Cancer Research Center | |||||
Chicago, Illinois, United States, 60637-1470 | |||||
United States, Iowa | |||||
Holden Comprehensive Cancer Center at The University of Iowa | |||||
Iowa City, Iowa, United States, 52242-1009 | |||||
United States, Pennsylvania | |||||
University of Pennsylvania Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19104-4283 |
Gynecologic Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Ming-teh D. Chen, MD | Women's Cancer Center - Los Gatos |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066377, GOG-9702 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003382 |
Health Authority: | United States: Federal Government |
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