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

Primary Purpose

Pancreatic Cancer, Metastatic

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine, Erlotinib, OSI-906

Gemcitabine, Erlotinib

About this trial

This is an interventional treatment trial for Pancreatic Cancer, Metastatic focused on measuring Metastatic, Pancreas, Cancer, Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gemcitabine, Erlotinib, OSI-906

Gemcitabine, Erlotinib

Arm Description

Experimental treatment arm

Standard treatment arm

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01600807

First Posted

August 8, 2011

Last Updated

June 25, 2013

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01600807

Brief Title

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

Official Title

Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study was pending major changes and was on hold, pending activation; administratively withdrawn; will be submitted as a new protocol if study is revised.

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Metastatic

Keywords

Metastatic, Pancreas, Cancer, Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine, Erlotinib, OSI-906

Arm Type

Experimental

Arm Description

Experimental treatment arm

Arm Title

Gemcitabine, Erlotinib

Arm Type

Active Comparator

Arm Description

Standard treatment arm

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, Erlotinib, OSI-906

Other Intervention Name(s)

Gemzaar, Tarceva

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, Erlotinib

Other Intervention Name(s)

Gemzaar, Tarceva

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with adverse events as a measure of safety and tolerability

Description

Time Frame

1 years

Title

Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression-free survival among patients receiving gemcitabine + erlotinib vs. gemcitabine + erlotinib + OSI-906

Description

Time Frame

2 years

Title

Tumor response rate among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Wolpin, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02214

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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