Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103. * Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients. OUTLINE: This is a dose-escalation study. Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103. Patients are followed between 1-3 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Interventions
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma * Recurrent disease following prior initial therapy with platinum-based regimen * No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease * No more than 1 prior non-platinum, non-taxane regimen * At least 1 site of radiographically measurable disease AND/OR * CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples PATIENT CHARACTERISTICS: Age * Not specified Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN * Alkaline phosphatase less than 1.5 times ULN Renal * Creatinine no greater than 1.5 mg/dL Other * No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs * No active uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy and recovered Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * At least 4 weeks since prior endocrine therapy and recovered Radiotherapy * At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered Surgery * Not specified Other * At least 4 weeks since other prior investigational drugs and recovered
Countries
United States
Outcome results
None listed