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

This study is not yet open for participant recruitment.
Verified May 2012 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01600807
First received: August 8, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer, Metastatic
 Drug: Gemcitabine, Erlotinib, OSI-906
Drug: Gemcitabine, Erlotinib
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 72
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Gemzaar
  • Tarceva
Active Comparator: Gemcitabine, Erlotinib
Standard treatment arm
 Drug: Gemcitabine, Erlotinib
Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD
Other Names:
  • Gemzaar
  • Tarceva

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600807

Contacts
Contact: Brian Wolpin, MD, MPH 617-632-6942 bwolpin@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Brian Wolpin, MD, MPH            
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: David Ryan, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Brian Wolpin, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Brian Wolpin, MD, MPH, Overall PI, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01600807     History of Changes
Other Study ID Numbers: 11-148
Study First Received: August 8, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic
Pancreas
Cancer
Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Pancreatic Neoplasms
Carcinoma, Ductal, Breast
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Breast Diseases
Skin Diseases
Pancreatin
Pancrelipase
Gemcitabine
Erlotinib
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013