Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00008060
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic adenocarcinoma of the colon or rectum
* Unresectable disease
* Measurable or evaluable disease
* No partial or complete bowel obstruction
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 4,000/mm\^3
* Platelet count greater than 150,000/mm\^3
Hepatic:
* Bilirubin less than 1.25 times upper limit of normal (ULN)
* Alkaline phosphatase less than 5 times ULN
* AST or ALT less than 3 times ULN
* No Gilbert's syndrome or other congenital abnormality of biliary transport (e.g., Crigler-Najjar syndrome or Dubin-Johnson syndrome)
Renal:
* Creatinine clearance greater than 50 mL/min OR
* Glomerular filtration rate normal
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other uncontrolled medical illness
* No other prior or concurrent malignancy that would preclude study entry
* No chronic diarrhea or inflammatory bowel disease
* No grade 2 or greater pre-existing neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 6 months since prior adjuvant chemotherapy
* Prior adjuvant fluorouracil allowed
* No prior chemotherapy for metastatic disease
* No prior oxaliplatin or irinotecan
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* No prior transplantation surgery requiring immunosuppressive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00008060
Study Brief:
Protocol Section:
NCT00008060