S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That C… (NCT00049335) | Clinical Trial Compass
CompletedPhase 2
S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
United States29 participantsStarted 2003-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling