A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336700
Recruitment Status : Terminated (Study published November 2010 and no further work will be done)
First Posted : June 14, 2006
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Genentech, Inc.
Information provided by (Responsible Party):
Herbert J. Zeh, III MD, FACS, University of Pittsburgh

Brief Summary:
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Erlotinib Phase 2

Detailed Description:

PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.

STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.

Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Study Start Date : June 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gemcitabine and Erlotinib
Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months
Drug: Gemcitabine
1500mg/m2 IV over 150 min IV q 2 weeks 4 months
Other Name: Gemzar
Drug: Erlotinib
150 mg/d Daily, oral 12 months
Other Name: Tarceva

Primary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
    The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.

  2. 1-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
  3. 2-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]

Secondary Outcome Measures :
  1. Estimated 1&2 Year Overall Survival (OS) [ Time Frame: Up to 60 months ]
    Time from from date of first study therapy to to death from any cause.

  2. Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR) [ Time Frame: Up to 60 months ]
    Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).

  3. KRAS Mutational Status [ Time Frame: Up to 60 months ]
    KRAS mutation status in resected tumor specimens.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.
  • Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.
  • Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.
  • Adjuvant therapy should start within 10 weeks of surgery
  • Age 18 years or older
  • ECOG performance status of 0 - 1 (see Appendix A)
  • Ability to take oral medications without difficulty
  • Adequate bone marrow function as evidenced by an absolute neutrophil content (ANC) > 1500/mL and platelet count > 100,000/mL
  • Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance > 50 ml/minute if above upper institutional limits (ULN)
  • Adequate hepatic function as evidenced by ALT and total bilirubin within 2 times ULN.
  • Provision of written informed consent.
  • Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Exclusion Criteria:

  • Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)
  • Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).
  • Known severe hypersensitivity to erlotinib or any of the excipients of these products
  • Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.
  • Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort. Other agents which inhibit CYP3A4 may be used with caution (Appendix B)
  • Treatment with a non-approved or investigational drug prior to treatment.
  • Incomplete healing from previous oncologic or other major surgery.
  • Pregnancy or breast feeding (women of childbearing potential).
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336700

United States, Pennsylvania
UPMC Cancer Centers Network
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Herbert J. Zeh, III MD, FACS
Genentech, Inc.
Principal Investigator: Herb Zeh, M.D. University of Pittsburgh

Responsible Party: Herbert J. Zeh, III MD, FACS, Principal Investigator, University of Pittsburgh Identifier: NCT00336700     History of Changes
Other Study ID Numbers: 06-016
First Posted: June 14, 2006    Key Record Dates
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016
Last Verified: July 2016

Keywords provided by Herbert J. Zeh, III MD, FACS, University of Pittsburgh:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors