Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

NYU Langone Health

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer

Interventions

oxaliplatinDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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