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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00040820
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy
* Locally advanced OR
* Metastatic disease
* Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR
* Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens
* Documented radiological disease progression after last anticancer treatment
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 75,000/mm3
Hepatic:
* SGOT or SGPT no greater than 6 times upper limit of normal (ULN)
* Bilirubin no greater than 2 mg/dL
* Alkaline phosphatase no greater than 5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* Adequate organ function and medically stable
* No known concurrent peripheral neuropathy
* Absence of deep tendon reflexes as the sole neurologic abnormality is allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 30 days since prior chemotherapy
* No prior oxaliplatin-based chemotherapy
* No other concurrent investigational chemotherapy agents
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 30 days since prior radiotherapy
Surgery:
* See Disease Characteristics
* At least 30 days since prior major surgical procedure or intervention
Other:
* At least 30 days since other prior anticancer therapy
* No other concurrent anticancer agents
* No concurrent participation in any other investigational studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040820
Study Brief:
Protocol Section:
NCT00040820