Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal… (NCT02333188) | Clinical Trial Compass
CompletedPhase 1
Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
United States50 participantsStarted 2014-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 childbeari…
What they're measuring
1
DLT rate in course 1 for each of the three genotype groups, graded according to NCI CTCAE v 4.0