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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00654160 |
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Date of registration:
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04/04/2008 |
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Primary sponsor: |
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Public title:
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Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer
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Scientific title:
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A Pharmacogenetic-Based Phase I Trial of Irinotecan, 5-Fluorouracil, and Leucovorin (FOLFIRI) in Patients With Advanced Gastrointestinal Cancer |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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70 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00654160 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert McWilliams, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anal Cancer
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Carcinoma of the Appendix
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Colorectal Cancer
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Esophageal Cancer
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Extrahepatic Bile Duct Cancer
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Gallbladder Cancer
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Gastric Cancer
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Gastrointestinal Carcinoid Tumor
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Gastrointestinal Stromal Tumor
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Liver Cancer
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Pancreatic Cancer
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Small Intestine Cancer
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Intervention(s)
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Drug: fluorouracil
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Drug: irinotecan hydrochloride
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Drug: leucovorin calcium
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Other: pharmacogenomic studies
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Other: pharmacological study
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Primary Outcome(s)
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Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy
[Time Frame: Yes]
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Secondary Outcome(s)
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Response rate of genotype-based dosing in the subset of patients that has colorectal cancer
[Time Frame: No]
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Secondary ID(s)
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CDR0000592931
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MC064G
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NCI-2009-01216
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P30CA015083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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