Expired Study
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Cleveland, Ohio 44106


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 combination chemotherapy in treating patients who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. - Determine the pharmacokinetic parameters of this regimen in these patients. - Determine the antitumor response of these patients treated with this regimen. OUTLINE: This is a dose-escalation study of irinotecan and capecitabine. Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy - Bidimensionally measurable or evaluable disease - No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 4,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10.0 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 2 times normal Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - No known hypersensitivity to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior large-field radiotherapy and recovered Surgery: - Not specified


NCT ID:

NCT00006465


Primary Contact:

Principal Investigator
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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