Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

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. 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.


Criteria:

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


NCT ID:

NCT00004059


Primary Contact:

Study Chair
Gary K. Schwartz, 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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.