Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02333188

Run by

University of Chicago

People needed

50

Starts

2014-12-01

Expected to finish

2017-12-01

Last updated by the study team

2023-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that FOLFIRABRAX is a reasonable therapeutic option
• 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

You may not qualify if…

• Prior chemotherapy or radiation therapy for any cancer
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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