Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer (NCT00654160) | Clinical Trial Compass
CompletedPhase 1
Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer
United States7 participantsStarted 2008-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with fluorouracil and leucovorin in treating patients with advanced gastrointestinal cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy