Expired Study
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Jacksonville, Florida 32209


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 II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.


Study summary:

OBJECTIVES: - Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. - Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen. - Determine the 1-year survival and overall survival of patients treated with this regimen. - Determine the toxicity and safety profile of this regimen in these patients. - Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma - At least 1 measurable lesion - At least 10 mm by spiral CT scan - At least 20 mm by conventional techniques - Bone metastases, ascites, or pleural effusions are not considered measurable disease - No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present) - No known Gilbert's disease Renal: - Creatinine no greater than 1.5 times ULN - Creatinine clearance at least 50 mL/min Cardiovascular: - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No cardiac arrhythmias uncontrolled with medication - No myocardial infarction within the past 12 months Gastrointestinal: - Able to swallow tablets - No lack of physical integrity of the upper gastrointestinal tract - No malabsorption syndrome Other: - No prior unanticipated severe reaction to fluoropyrimidine therapy - No hypersensitivity to fluorouracil - No history of uncontrolled seizures or CNS disorders - No psychological illness or condition that would preclude study entry - No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No serious infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy - No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer - No concurrent prophylactic hematopoietic growth factors Chemotherapy: - At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy - No prior chemotherapy for metastatic colorectal cancer - No prior irinotecan or capecitabine - No other concurrent cytotoxic agents Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) - No concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgery and recovered - No prior organ allograft Other: - At least 4 weeks since prior participation in an investigational drug study - No other concurrent investigational drugs


NCT ID:

NCT00022698


Primary Contact:

Study Chair
Mike Andria
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32209
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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