Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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. PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy. Determine the safety of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression. Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients. Patients are followed every 2 months for at least 6 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)

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

Intervention / Treatment
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* Drug: topotecan hydrochloride
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer Stage IIIB, IIIC, or IV Surgically staged and debulked Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria: No evidence of cancer by history or physical examination CA 125 no greater than 35 units/mL No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray Must have received at least 5 courses of first-line chemotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,200/mm^3 Platelet count at least 90,000/mm^3 Hepatic Bilirubin normal ALT and AST less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 ULN Renal Creatinine clearance at least 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 weeks since prior first-line chemotherapy At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer) No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy No prior abdominopelvic radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics No concurrent surgery Other No other concurrent antitumor therapy

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 |
| --- |
|Drug: topotecan hydrochloride|nan|
|Procedure: adjuvant therapy|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 III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer