Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
NCT ID: NCT02333188
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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I. To determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of three uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) genotype groups (\*1/\*1, \*1/\*28, \*28/\*28) using genotype-guided dosing of irinotecan (irinotecan hydrochloride) as part of the FOLFIRABRAX regimen.
SECONDARY OBJECTIVES:
I. To determine the cumulative dose of each chemotherapy drug (nab-paclitaxel \[paclitaxel albumin-stabilized nanoparticle formulation\], irinotecan, 5-FU \[fluorouracil\]) administered in each genotype group.
II. To determine the response rates (in patients with measurable disease) by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) for each different disease (pancreatic cancer, biliary tract cancer, esophageal/gastric cancer, adenocarcinoma of unknown primary) treated in the study.
OUTLINE:
Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (FOLFIRABRAX)
Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Leucovorin Calcium
Given IV
Irinotecan Hydrochloride
Given IV
Fluorouracil
Given IV
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Leucovorin Calcium
Given IV
Irinotecan Hydrochloride
Given IV
Fluorouracil
Given IV
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Life expectancy \> 3 months
* Absolute neutrophil count (ANC) \>= 1500/ul
* Hemoglobin \> 9 g/dL
* Platelets \> 100,000/ul
* Total bilirubin =\< 1.25 times upper limit of normal
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal
* Alkaline phosphatase =\< 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
* Creatinine =\< 1.5 mg/dL
* Measurable or non-measurable disease will be allowed, but only those with measurable disease will be evaluable for the response rate endpoint
* Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
* Negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
* Signed informed consent
Exclusion Criteria
* Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version \[v.\] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement
* Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
* Documented brain metastases
* Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment
* Active uncontrolled bleeding
* Pregnancy or breastfeeding
* Major surgery within 4 weeks
* Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%
* Patients taking substrates, inhibitors and inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible
* Patients with any polymorphism in UGT1A1 other than \*1 or \*28 (e.g., \*6)
* History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis or connective tissue disorders
* Subjects known to be human immunodeficiency virus (HIV)-positive, including those on combination antiretroviral therapy, are ineligible
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Manish Sharma
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Fort Wayne Medical Oncology/Hematology
Fort Wayne, Indiana, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Virginia Mason
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2014-02407
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB14-0595
Identifier Type: OTHER
Identifier Source: secondary_id
IRB14-0595
Identifier Type: -
Identifier Source: org_study_id
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