Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: gemcitabine hydrochloride
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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