Orange, California 92868

  • Primary Peritoneal Cavity Cancer

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.


Study summary:

OBJECTIVES: - Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim (G-CSF) in patients with refractory ovarian or fallopian tube cancer. - Describe and quantitate the clinical toxicities of these regimens in this patient population. 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer - No borderline ovarian cancer - Extra-ovarian papillary serous tumors eligible - Must not be eligible for any higher priority phase II or III GOG protocol PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGOT no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 mg/dL - Elevated levels of alkaline phosphatase allowed Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias - No uncontrolled hypertension Other: - No other active malignancy - No prior malignancy within the past 5 years except nonmelanomatous skin cancer - No active infection - No underlying medical problem that would prevent compliance - No known hypersensitivity to E. coli-derived drug preparations - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Must have received at least 1 prior platinum- and paclitaxel-based regimen - At least 4 weeks since prior chemotherapy - No prior topotecan and/or gemcitabine - No prior chemotherapy for a different prior malignancy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to more than 10% of bone marrow - At least 2 weeks since limited field radiation therapy Surgery: - Not specified


NCT ID:

NCT00003382


Primary Contact:

Study Chair
Ming-teh D. Chen, MD
Women's Cancer Center - Los Gatos


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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