Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
NCT02333188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-05-31
Summary
This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
Conditions
- 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
Interventions
- DRUG
-
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
- DRUG
-
Leucovorin Calcium
Given IV
- DRUG
-
Irinotecan Hydrochloride
Given IV
- DRUG
-
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Chicago
lead OTHER
Principal Investigators
-
Manish Sharma · University of Chicago Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- United States
Study Locations
More Related Trials
-
Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus
NCT00005607 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
NCT04361708 ·Status: RECRUITING ·Phase: PHASE1
-
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
NCT06654037 ·Status: RECRUITING ·Phase: PHASE1
-
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
NCT05677490 ·Status: RECRUITING ·Phase: PHASE3
-
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer
NCT01688336 ·Status: TERMINATED ·Phase: PHASE2
-
Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer
NCT01383343 ·Status: COMPLETED ·Phase: PHASE1
-
FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
NCT01747551 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
NCT01494363 ·Status: UNKNOWN ·Phase: PHASE2
-
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
NCT01862315 ·Status: COMPLETED ·Phase: PHASE2
-
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
NCT00976768 ·Status: COMPLETED ·Phase: PHASE2
-
High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28
NCT03329183 ·Status: UNKNOWN ·Phase: PHASE2
-
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
NCT00514020 ·Status: COMPLETED ·Phase: PHASE2
-
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
NCT02138617 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver
NCT03069950 ·Status: WITHDRAWN ·Phase: PHASE2
-
C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer
NCT02344810 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors
NCT00138177 ·Status: COMPLETED ·Phase: PHASE1
-
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
NCT03773367 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
NCT07042685 ·Status: RECRUITING ·Phase: PHASE2
-
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
NCT04251715 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
FOLFIRINOX for 2nd-line Treatment of BTC
NCT03778593 ·Status: COMPLETED ·Phase: PHASE2
-
Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
NCT00004127 ·Status: COMPLETED ·Phase: PHASE2
-
FOLFIRI or FOLFOX With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Colon or Rectum
NCT00077233 ·Status: TERMINATED ·Phase: PHASE3
-
Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers
NCT03291899 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
NCT05564403 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Second-line Therapy for Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma
NCT03837977 ·Status: COMPLETED ·Phase: PHASE2