Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Gastrointestinal Agents

Hematinics

Herbal and Botanical

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Pancrelipase

Pasireotide

Pancreatin

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Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Hormones

Hormone Antagonists

Cola

Folate

Vitamin B9

Treatment will be administered on an outpatient basis. FOLFIRI is administered by IV infusion every 2 weeks. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline.

SOM 230 will be administered as an intramuscular dose determined by the dosing schema, every 28 days.

Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease.

SOM230C LAR

FOLFIRI Infusion

Richard Kim, M.D.

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.

The goal of this clinical research study is to learn if the study drug SOM 230, also known as Pasireotide long-acting release (LAR), in addition to standard therapy of FOLFIRI (5FU, leucovorin, and irrinotecan) can shrink or slow the growth of gastrointestinal malignancies. The safety of this drug in combination with standard chemotherapy (FOLFIRI) will also be studied. The participant's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

Phase I Trial of Combination of FOLFIRI and SOM 230

Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies

To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.

Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.

Evaluate the frequency of tumor response by dose cohort according to the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

Novartis

H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for folfiri infusion