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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003382 |
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 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 |
Biological: filgrastim Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride |
Phase I |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Study Chair: | Ming-teh D. Chen, MD | Women's Cancer Center - Los Gatos |
More Information
| Study ID Numbers: | CDR0000066377, GOG-9702 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003382 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
|
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 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 Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases |