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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors. - Determine the clinical pharmacokinetics of this regimen, as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients. - Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients. - Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen. OUTLINE: This is a dose-escalation, open-label, non-randomized study of flavopiridol. Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. During the first week of the second course, patients receive flavopiridol alone on day 1 and irinotecan alone on day 2. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment. An additional 10 patients are treated at the MTD. PROJECTED ACCRUAL: A total of 44-50 patients will be accrued for this study within 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists - Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy - Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy - No known CNS metastasis or primary CNS tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Total 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 Cardiovascular: - No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months Other: - Not pregnant or nursing (during and for at least 2 months after study) - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 2 months after study - No concurrent serious or uncontrolled infection - HIV negative - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior irinotecan allowed Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics Other: - Recovered from prior therapy - No other concurrent investigational medication - No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements - No concurrent subcutaneous heparin or heparinoids


NCT ID:

NCT00006485


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 21, 2017

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