Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, 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 combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Determine the qualitative and quantitative toxic effects of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. Determine the antitumor activity of this treatment regimen in these patients. Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed through day 30. PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Official Title
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A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: oxaliplatin
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer Prior chemotherapy required Measurable or evaluable disease No symptomatic, untreated brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 4 months Hematopoietic: WBC greater than 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia Other: No other active cancer No prior allergy to platinum compounds No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study No other uncontrolled concurrent illness (e.g., infection) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No concurrent colony stimulating factors during topotecan administration Chemotherapy: See Disease Characteristics No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to whole pelvic field At least 2 weeks since prior radiotherapy and recovered Surgery: No unresolved sequelae resulting from prior surgery Other: At least 4 weeks since other prior investigational drug No other concurrent investigational agents No other concurrent anticancer 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: oxaliplatin|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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recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer