A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Gynecologic Oncology Group
- Locations
- 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •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
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias
- •No uncontrolled hypertension
- •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
- •Not specified
Exclusion Criteria
- Not provided