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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00080951
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of colorectal adenocarcinoma
* Metastatic disease
* Not curable by surgery or amenable to radiotherapy with curative intent
* Measurable disease
* Patients with only lesions measuring ≥ 1 cm but \< 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments
* No known CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST ≤ 5 times upper limit of normal (ULN)
* Bilirubin ≤ 0.5 mg/dL above ULN
Renal
* Creatinine ≤ 1.5 times ULN OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No unstable angina
* No symptomatic congestive heart failure
* No serious uncontrolled cardiac arrhythmia
Pulmonary
* No prior clinical diagnosis of interstitial lung disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active or uncontrolled infection
* No other concurrent serious illness
* No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with function
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* At least 6 months since prior adjuvant chemotherapy
* No prior fluorouracil for advanced colorectal cancer
* No prior adjuvant oxaliplatin
* No prior adjuvant irinotecan
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to \> 25% of bone marrow
Surgery
* At least 4 weeks since prior major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00080951
Study Brief:
Protocol Section:
NCT00080951