Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
|Acinar Cell Adenocarcinoma of the Pancreas Adenocarcinoma of the Gallbladder Adenocarcinoma of Unknown Primary Adult Primary Cholangiocellular Carcinoma Advanced Adult Primary Liver Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Diffuse Adenocarcinoma of the Stomach Duct Cell Adenocarcinoma of the Pancreas Intestinal Adenocarcinoma of the Stomach Localized Unresectable Adult Primary Liver Cancer Metastatic Carcinoma of Unknown Primary Metastatic Extrahepatic Bile Duct Cancer Mixed Adenocarcinoma of the Stomach Mucinous Adenocarcinoma of the Colon Mucinous Adenocarcinoma of the Rectum Newly Diagnosed Carcinoma of Unknown Primary Signet Ring Adenocarcinoma of the Colon Signet Ring Adenocarcinoma of the Rectum Stage III Pancreatic Cancer Stage IIIA Colon Cancer Stage IIIA Gallbladder Cancer Stage IIIA Gastric Cancer Stage IIIA Rectal Cancer Stage IIIB Colon Cancer Stage IIIB Gallbladder Cancer Stage IIIB Gastric Cancer Stage IIIB Rectal Cancer Stage IIIC Colon Cancer Stage IIIC Gastric Cancer Stage IIIC Rectal Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer Stage IVA Colon Cancer Stage IVA Gallbladder Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Gallbladder Cancer Stage IVB Rectal Cancer Unresectable Extrahepatic Bile Duct Cancer||Drug: oxaliplatin Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: fluorouracil Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Genotype-guided Dosing Study of mFOLFIRINOX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies|
- DLT rate in course 1 for each of the two most common genotype groups (*1*1 and *1*28) [ Time Frame: 4 weeks ]To show that the DLT rate is less than 33% with at least 70-80% confidence, which is comparable to the standard 3+3 phase I design with 0 out of 3 or 1 out of 6 patients experiencing a DLT.
- Response rates (by RECIST 1.1) for patients with each different type of gastrointestinal malignancy [ Time Frame: Up to 1 year ]
- Cumulative dose intensity of irinotecan hydrochloride [ Time Frame: Up to 1 year ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (mFOLFIRINOX)
Patients receive oxaliplatin IV over 2 hours on, irinotecan hydrochloride IV over 1.5 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: irinotecan hydrochloride
Other Names:Drug: leucovorin calcium
Other Names:Drug: fluorouracil
Other Names:Other: laboratory biomarker analysis
I. To determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of two UGT1A1 genotype groups (*1*1, *1*28) using genotype-guided dosing of irinotecan as part of the modified (m) FOLFIRINOX regimen.
I. To determine the cumulative dose intensity of irinotecan achieved in each genotype group.
II. To determine the response rates by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) for each different disease (pancreatic cancer, biliary cancers, gastric cancer, colorectal cancer, adenocarcinoma of unknown primary) treated in the study.
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 1.5 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643499
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Hedy L. Kindler 773-702-0360 firstname.lastname@example.org|
|Principal Investigator: Hedy L. Kindler|
|Evanston CCOP-NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Robert De Marsh 847-570-1381 email@example.com|
|Principal Investigator: Robert De Marsh|
|Principal Investigator:||Hedy Kindler||University of Chicago Comprehensive Cancer Center|