S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.

Detailed Description
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OBJECTIVES: Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study. Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients. Determine the toxicity and tolerability of this drug in these patients. Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug. Determine the clinical pharmacology of this drug in these patients. Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature. OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59). Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.

Official Title
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Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection Measurable disease No known brain metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age 70 and over OR 18 to 59 Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN Renal Creatinine no greater than 2 times ULN Creatinine clearance greater than 50 mL/min Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No known seizure disorder No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for advanced cancer Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4 weeks since prior sorivudine or brivudine No concurrent sorivudine or brivudine

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle. | Drug: capecitabine<br>* 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle<br>* Other names: NSC-712807;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling |  | Registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival |  | 2 years | 
| Toxicity |  | 3 years | 
| Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels |  | 3 years | 
| Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature |  | 3 years | 
| Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine |  | 3 years | 

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