Expired Study
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New York, New York 10016


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00006391


Primary Contact:

Study Chair
Howard S. Hochster, MD
New York University School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 16, 2017

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