Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors. - Determine the toxic effects of this regimen in these patients. - Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients. - Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. OUTLINE: This is a dose de-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value - Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST less than 2 times ULN - Alkaline phosphatase less than 2 times ULN - Lactic dehydrogenase less than 2 times ULN Renal: - Creatinine no greater than 1.5 times ULN Other: - HIV negative - No active uncontrolled bacterial, viral, or fungal infection - No nonmalignant systemic disease that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No prior irinotecan Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control - No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture) Surgery: - See Disease Characteristics - At least 2 weeks since prior major surgery Other: - No concurrent anticoagulants except warfarin or subcutaneous heparin


NCT ID:

NCT00024141


Primary Contact:

Study Chair
Patrick J. Creaven, MBBS, PhD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
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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