Ovarian Cancer Clinical Trial
Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
New York New York, 10016, United States
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