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

NCT ID: NCT01600807

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer, Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, Erlotinib

Standard treatment arm

Group Type: ACTIVE_COMPARATOR

Gemcitabine, Erlotinib

Intervention Type: DRUG

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

Gemcitabine, Erlotinib, OSI-906

Experimental treatment arm

Group Type: EXPERIMENTAL

Gemcitabine, Erlotinib, OSI-906

Intervention Type: DRUG

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

Interventions

Gemcitabine, Erlotinib, OSI-906

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

Intervention Type: DRUG

Gemcitabine, Erlotinib

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

Intervention Type: DRUG

Other Intervention Names

Gemzaar; Tarceva; Gemzaar; Tarceva

Eligibility Criteria

Inclusion Criteria

• Metastatic pancreatic ductal adenocarcinoma
• Measurable disease
• Life expectancy > 12 weeks
• Normal organ and marrow function
• Fasting blood glucose </= 150 mg/dL
• Able to swallow pills

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Brian Wolpin, MD, MPH

Overall PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Wolpin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-148

Identifier Type: -

Identifier Source: org_study_id