OSI-906 With Gemcitabine And Erlotinib For Metastatic Ductal Adenocarcinoma Of The Pancreas

Study Overview

OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth. Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

This study will be conducted in two parts: a phase I study and a phase II study. In both instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth, twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth, once a day, every day. At every visit subjects will have a physical exam and blood tests. An EKG will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done every 2 cycles (8 weeks). Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.

Pancreatic Cancer, Metastatic

DRUG: Gemcitabine, Erlotinib, OSI-906
DRUG: Gemcitabine, Erlotinib

11-148

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-08-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-25
First Submitted that Met QC Criteria 2012-05-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-26
First Posted (ESTIMATED) 2012-05-17	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine, Erlotinib, OSI-906 Experimental treatment arm	DRUG: Gemcitabine, Erlotinib, OSI-906 Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID
ACTIVE_COMPARATOR: Gemcitabine, Erlotinib Standard treatment arm	DRUG: Gemcitabine, Erlotinib, OSI-906 Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID DRUG: Gemcitabine, Erlotinib Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine, Erlotinib, OSI-906

Experimental treatment arm

DRUG: Gemcitabine, Erlotinib, OSI-906

Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID

ACTIVE_COMPARATOR: Gemcitabine, Erlotinib

Standard treatment arm

DRUG: Gemcitabine, Erlotinib, OSI-906

Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID

DRUG: Gemcitabine, Erlotinib

Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD

Primary Outcome Measures	Measure Description	Time Frame
Number of patients with adverse events as a measure of safety and tolerability	Phase I study to assess the safety, tolerability and maximally tolerated dose (MTD) of OSI-906 administered in combination with gemcitabine and erlotinib is patients with metastatic pancreatic ductal adenocarcinoma	1 years
Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906	Phase II trial to assess overall survival associated with OSI-906, gemcitabine and erlotinib compared with gemcitabine and erlotinib alone in patients with previous untreated metastatic pancreatic ductal adenocarcinoma	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival among patients receiving gemcitabine + erlotinib vs. gemcitabine + erlotinib + OSI-906	To assess progression-free survival associated with OSI-906, gemcitabine and erlotinib compared to gemcitabine and erlotinib alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma	2 years
Tumor response rate among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906	To assess tumor response rate associated with OSI-906, gemcitabine and erlotinib compared to gemcitabine and erlotinib alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Metastatic pancreatic ductal adenocarcinoma
Measurable disease
Life expectancy > 12 weeks
Normal organ and marrow function
Fasting blood glucose
Able to swallow pills

Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
Receiving any other experimental agent
Known brain metastases
History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
Use of enzyme-inducing anti-epileptic drugs
Diabetes mellitus which requires the use of exogenous insulin for glucose control
Major surgery within 4 weeks of the start of study treatment
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Use of strong or moderate CYP1A2 inhibitors/inducers
Pregnant or breast feeding
History of a different malignancy unless disease-free for at least 3 years
HIV positive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record