Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
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|ClinicalTrials.gov Identifier: NCT02333188|
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of Unknown Primary Adult Cholangiocarcinoma Gallbladder Carcinoma Gastric Adenocarcinoma Malignant Gastrointestinal Neoplasm Metastatic Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma Stage III Ampulla of Vater Cancer Stage III Pancreatic Cancer Stage IIIA Gallbladder Cancer Stage IIIA Gastric Cancer Stage IIIB Gallbladder Cancer Stage IIIB Gastric Cancer Stage IV Ampulla of Vater Cancer Stage IV Gallbladder Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer||Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation Drug: Leucovorin Calcium Drug: Irinotecan Hydrochloride Drug: Fluorouracil Other: Laboratory Biomarker Analysis||Phase 1 Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Genotype-Guided Dosing Study of FOLFIRABRAX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: 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.
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Drug: Leucovorin Calcium
Other Name: CF
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
- DLT rate in course 1 for each of the three genotype groups, graded according to NCI CTCAE v 4.0 [ Time Frame: 4 weeks ]
- Incidence of adverse events graded according to NCI CTCAE v 4.0 [ Time Frame: Up to 6 months ]Adverse events will be summarized by type, grade, and attribution.
- Response rates (by RECIST 1.1) for patients with each different type of gastrointestinal malignancy [ Time Frame: Up to 6 months ]These results will be compared descriptively to appropriate historical controls. Exact 90% confidence intervals will be generated for the response rates.
- Cumulative doses of the drugs will be calculated as the sum of all doses received on protocol therapy for each patient [ Time Frame: Up to 6 months ]The means and standard deviations for patients in each genotype group will be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333188
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University Health System|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|United States, Indiana|
|Fort Wayne Medical Oncology/Hematology|
|Fort Wayne, Indiana, United States, 46845|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Washington|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Manish Sharma||University of Chicago Comprehensive Cancer Center|