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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

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