Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00017017


Primary Contact:

Study Chair
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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