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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00654160
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Biopsy confirmed diagnosis of gastrointestinal cancer
* Advanced, unresectable disease
* Confirmation of UGT1A1 TA indel genotype
* Measurable or evaluable (non-measurable) disease
* Measurable disease is defined as ≥ 1 lesion that can be accurately measured (longest diameter to be recorded) as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT scan
* Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules, palpable lymph nodes)
* Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung
* The following are considered non-measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusions
* Lymphangitis cutis/ pulmonis
* Inflammatory breast disease
* Abdominal masses (not followed by CR scan or MRI)
* Cystic lesions
* All other lesions (or sites of disease), including small lesions (longest diameter \< 2.0 cm with conventional techniques or as \< 1.0 cm with spiral CT)
* No known central nervous system metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Inclusion criteria
* Life expectancy ≥ 12 weeks.
* ECOG performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* SGOT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases)
* Total Bilirubin ≤ ULN for patients in group 3 and ≤ 2.0 times ULN for patients in groups 1 and 2
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for the duration of study treatment
* Willing to provide blood samples for mandatory translational studies
Exclusion criteria
* Known allergy to irinotecan hydrochloride-related agents (e.g., topotecan), 5-fluorouracil, and/or leucovorin calcium
* Active or uncontrolled infection
* Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
PRIOR CONCURRENT THERAPY:
* Recovered from all toxicities
* More than 4 weeks since prior major surgery
* More than 2 weeks since completion of prior radiotherapy
* No prior radiotherapy to \> 25% of bone marrow
* More than 2 week since prior cytotoxic chemotherapy, biologic therapy, or immunotherapy
* No concurrent sargramostim (GM-CSF)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00654160
Study Brief:
Protocol Section:
NCT00654160