Colorectal Cancer
Conditions
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Brief summary
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
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.
Interventions
DRUGcapecitabine
1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, on Days 1-14 of 21 day cycle
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling | Registration |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed