Phase I Trial of Combination of FOLFIRI and SOM 230
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:||February 2016|
|Estimated Primary Completion Date:||February 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434069
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|