Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
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, primary peritoneal cavity cancer
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
DRUGgemcitabine hydrochloride
DRUGtopotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed