Expired Study
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New York, New York 10021


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose, dose limiting toxicity, and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors. - Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients. - Obtain preliminary data on the therapeutic activity of this regimen in these patients. OUTLINE: This is a dose escalation study of fluorouracil. Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study within approximately 14 months.


DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists - Measurable or evaluable disease - No CNS metastasis or primary CNS malignancy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting - No cardiac arrhythmias or congestive heart failure within the past 6 months - Stable atrial fibrillation on standard treatment allowed at discretion of investigator Pulmonary: - DLCO at least 60% of predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study - No active serious or uncontrolled infection - HIV negative - No diabetes - No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered - Prior fluorouracil allowed Endocrine therapy: - Not specified Radiotherapy: - No prior mediastinal radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No concurrent anticonvulsant medications



Primary Contact:

Study Chair
Gary K. Schwartz, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


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: October 09, 2019

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