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:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT00025350
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Measurable disease
* Evidence of new or progressive metastatic disease within 6 months of last treatment
* Must have received prior systemic treatment with fluorouracil (and/or its analogs, with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or metastatic setting
* Metastatic tumor site accessible for biopsy
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver)
Renal:
* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing active or uncontrolled infections
* Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease
* No other uncontrolled illness or psychiatric illness/social situations that would preclude study
* Must be able to take and retain oral medications
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-, vascular endothelial growth factor receptor-, and epidermal growth factor receptor-targeted agents) for colorectal cancer
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No other prior systemic therapy for colorectal cancer
* No other prior investigational or approved agents for colorectal cancer
* No other concurrent investigational agents
* No concurrent antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00025350
Study Brief:
Protocol Section:
NCT00025350