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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00416494
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically documented adenocarcinoma of the colon or rectum
* Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
* No leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* AST/ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases)
* Bilirubin \< 1.5 times ULN
* Creatinine clearance \> 50 mL/min
* No unstable or poorly controlled hypertension (\> 150/100 mm Hg)
* Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is \< 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study and for at least 3-4 months after study completion
* No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months
* No known, existing, uncontrolled coagulopathy
* No clinically significant cardiac disease
* No congestive heart failure
* No symptomatic coronary artery disease
* No cardiac arrhythmias not well controlled with medication
* No myocardial infarction within the last 12 months
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab
* No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior sorivudine or brivudine
* At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen
* No major surgery within 4 weeks without complete recovery
* No prior chemotherapy for metastatic/recurrent disease
* No cancer immunotherapy or other biologic therapy while on therapy
* No radiotherapy while on study
* No hormonal therapy for cancer while on study
* No full-dose warfarin (INR of \> 1.5), heparin (\> 10,000 units/day), or thrombolytic agents
* Allopurinol and cimetidine should be discontinued prior to starting on this regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00416494
Study Brief:
Protocol Section:
NCT00416494