Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.

Detailed Description
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OBJECTIVES: Primary Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib, capecitabine, and irinotecan. Secondary Determine the time to progression in patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the overall survival of patients treated with this regimen. Determine the time to treatment failure in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days 1-21 in all subsequent courses. Patients also receive oral capecitabine twice daily on days 1-14 and irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response after 4 courses may temporarily discontinue treatment for no more than 4 weeks. After completion of study treatment, patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 21-44 patients will be accrued for this study within 7-18 months.

Official Title
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Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: celecoxib
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Locally recurrent or metastatic disease Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan Bone metastases, ascites, and pleural effusion are not considered measurable disease Measurable lesions must be located outside a previously irradiated field PATIENT CHARACTERISTICS: Performance status SWOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal No Gilbert's disease Renal Creatinine clearance > 50 mL/min Cardiovascular No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions: Congestive heart failure Symptomatic coronary artery disease Cardiac arrhythmias No myocardial infarction within the past year Gastrointestinal Must have a physically intact upper gastrointestinal tract Able to swallow tablets No history of peptic ulcer disease or gastroesophageal reflux No malabsorption syndrome Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs No other malignancy except curatively treated cancer with no evidence of active disease No unresolved bacterial infection requiring antibiotics No other serious infection No known allergy to study drugs or sulfa drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for colorectal cancer Patients relapsing > 6 months after completion of prior adjuvant chemotherapy allowed No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent anticancer radiotherapy Surgery Recovered from prior surgery No concurrent anticancer surgery Other Prior celecoxib for nonmalignant disorders allowed No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following: Rofecoxib Ibuprofen Naproxen Etodolac Oxaprozin Diflunisal Nabumetone Tolmetin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: celecoxib|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by RECIST criteria at every other course |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Toxicity |  |  | 
| Overall survival |  |  | 
| Time to treatment failure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer