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Digestive System Neoplasms

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Gastrointestinal Diseases

Pancreatic Diseases

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Gemcitabine

Pancrelipase

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Hormone Antagonists

Combination Therapy: Dose escalation of SOM 230 LAR and standard treatment with gemcitabine. Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV infusion. 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. The dose of gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest period.

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

We will attempt dose escalation starting at a lower level 1 of 40 mg since we are using SOM 230 LAR in combination with gemcitabine for the first time.

SOM 230 LAR

Fixed dose: 1000mg/m\^2 weekly x3 then 1 week off

Richard Kim, M.D.

The goal of this clinical research study is to learn if the study drug SOM 230 in addition to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The safety and tolerability of different doses of SOM 230 will also be studied. The participants' physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe and effective.

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 LAR and standard treatment with gemcitabine. We will utilize a staggered, sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 LAR when combined with standard doses of gemcitabine. Cycle will be defined as 28 days.

Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV infusion. 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. The dose of gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest period. SOM 230 LAR will be administered as an intramuscular dose determined by the dosing schema, every month.

SOM 230 and Gemcitabine in Advanced Pancreatic Cancer

Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer

Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)

Frequency counts and percentage will be used to summarize the progression-free survival (PFS) in 3 months period.

Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective tumor response will be summarized using frequency counts and percentage.

Frequency counts and percentage will be used to summarize the overall survival (OS) in 6 months period.

Spots Global Cancer Trial Database for som 230 lar

Every month we try and update this database with for som 230 lar cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for som 230 lar

Every month we try and update this database with for som 230 lar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for som 230 lar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.