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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT00513266
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board
* Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
* Must have at least one lesion of 30 mm or less
Exclusion criteria:
* History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Performance status ≤ 1
* Life expectancy \> 12 weeks
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine 1.25 x upper limit of normal (ULN)
* Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
* AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
* Woman and men of childbearing age must use adequate contraception
Exclusion criteria:
* Pregnancy (positive serum pregnancy test) or lactation
* Chronic diarrhea ≥ grade 2
* Other serious illness or medical condition including any of the following:
* Unstable cardiac disease requiring treatment
* Congestive heart failure or angina pectoris even if medically controlled
* Significant arrhythmias
* History of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
* Active uncontrolled infection
* Severe hypercalcemia
* Other serious underlying medical condition that could impair the ability of the patient to participate in the study
* Neuropathy \> grade 1 of any etiology
* Known DPD deficiency
* Known severe polyneuropathy
* Known allergy to Chinese hamster ovary cell proteins, other recombinant human or humanized antibodies, any excipients of bevacizumab formulation, or any other study drugs
* Chronic inflammatory bowel disease
* Acute or subacute intestinal occlusion
* History of previous arterial thromboembolism
* Uncontrolled hypertension
* Evidence of bleeding diathesis or coagulopathy
* Serious nonhealing wound, ulcer, or bone fracture
* History of tumor other than basocellular carcinoma of the skin
* Peripheral neuropathy \> grade 1 of any origin (e.g., alcohol)
* Significant traumatic injury within 28 days prior to study treatment
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
* No prior chemotherapy for metastatic disease
* Prior adjuvant chemotherapy permitted if interval since last treatment administration and recurrence is \> 6 months
* Major surgical procedure or open biopsy within 28 days prior to study treatment or anticipation of the need for major surgical procedure during the course of the study
* Treatment in a clinical trial within 30 days prior to study entry
* Concurrent treatment with other experimental drugs or other anticancer therapy
* Current or recent use (within 10 days prior to study treatment) of full-dose oral or parenteral anticoagulants for therapeutic purposes
* Chronic daily treatment with aspirin (\> 325 mg/day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00513266
Study Brief:
Protocol Section:
NCT00513266