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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT00016250
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic adenocarcinoma of the colon or rectum
* Bidimensionally measurable disease
* At least 2.0 x 2.0 cm
* Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting
* Must have had disease progression while receiving chemotherapy OR
* If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy)
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 9 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
* Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present)
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past 6 months
Gastrointestinal:
* No bowel obstruction
* No active uncontrolled malabsorption syndrome
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer
* No other active cancers, including stable disease on adjuvant therapy
* No other medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Chemotherapy
* At least 2 weeks since prior biologic therapy and recovered
Chemotherapy:
* See Disease Characteristics
* No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
* Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
Surgery:
* No prior total gastrectomy
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00016250
Study Brief:
Protocol Section:
NCT00016250