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This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
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Inclusion criteria
Patient must have a histologically proven adenocarcinoma of colon or rectum with metastases or local recurrence.
Patients must have at least one measurable lesion according to the RECIST criteria. Bone metastases, ascites and pleural effusion are not measurable.
Minimum indicator lesion size as follows:
Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques
Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.
Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
Patients must have a calculated creatinine clearance of greater than 50 ml/min.
Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
Patients must have recovered from any effects of surgery.
Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
Patients must provide a signed consent to participate in the study.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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