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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00118261
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal cancer
* Biopsy-accessible metastatic disease
* Measurable disease
* No CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* WBC ≥ 4,000/mm\^3 OR
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* No bleeding disorder
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* Albumin ≥ 2.5 g/dL
Renal
* Creatinine ≤ 1.5 mg/dL
* Urine protein:creatine ratio \< 1.0
Cardiovascular
* Blood pressure ≤ 150/100 mmHg
* No arterial thrombotic event within the past 6 months
* No New York Heart Association grade II-IV congestive heart failure
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after completion of study treatment
* No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other malignancy with \< 10% chance of relapse within 3 years
* No uncontrolled infection
* No severe uncontrolled illness that would preclude study participation
* No peripheral neuropathy interfering with function
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious non-healing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy, including oxaliplatin, for metastatic disease
* Prior adjuvant oxaliplatin allowed provided disease progressed \> 12 months after completion of oxaliplatin
* At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
* No more than 2 courses of prior mitomycin
* No concurrent chemotherapy
Endocrine therapy
* No concurrent anticancer hormonal therapy
Radiotherapy
* At least 2 weeks since prior radiotherapy
* No prior radiotherapy to \> 15% of bone marrow
* No concurrent radiotherapy
Surgery
* At least 4 weeks since prior major surgery
* At least 1 week since prior minor surgery
Other
* Recovered from prior therapy
* No prior epidermal growth factor receptor inhibitor therapy
* No other concurrent antineoplastic or antitumor therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00118261
Study Brief:
Protocol Section:
NCT00118261