Phase I Trial of Combination of FOLFIRI and SOM 230
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.
Drug: SOM230C LAR
Drug: FOLFIRI Infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies|
- Maximum Tolerated Dose (MTD) [ Time Frame: Average of 6 Months Per Participant ] [ Designated as safety issue: No ]To determine the maximum tolerated dose (using a standard 3+3 design), of SOM 230 and FOLFIRI.
- Number of Participants With Adverse Events (AEs) [ Time Frame: Average of 6 Months Per Participant ] [ Designated as safety issue: Yes ]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.
- Number of Participants With Tumor Response [ Time Frame: Average of 6 Months Per Participant ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Combination Therapy: FOLFIRI and SOM 230
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.
Drug: SOM230C LAR
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.
Other Name: Pasireotide LARDrug: FOLFIRI Infusion
Standard therapy of FOLFIRI
Other Name: 5-Fluorouracil [5FU], leucovorin [LV], and irrinotecan
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.
|Contact: Richard Kim, M.D.||firstname.lastname@example.org|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Irene Williams Elson 813-745-8458 email@example.com|
|Principal Investigator: Richard Kim, M.D.|
|Sub-Investigator: Khaldoun Almhanna, M.D.|
|Sub-Investigator: David Shibata, M.D.|
|Sub-Investigator: Jonathan Strosberg, M.D.|
|Sub-Investigator: Amit Mahipal, M.D.|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|