NCT00049335
S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
PHASE2
COMPLETED
NCT00049335
INTERVENTIONAL
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)
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.
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
Colorectal Cancer
- TREATMENT
-
- Type: DRUG
- Name: capecitabine
- Description: 1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, on Days 1-14 of 21 day cycle
- Arm Group Labels: Capecitabine
- SWOG Cancer Research Network