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

This study has been terminated.
(Study published November 2010 and no further work will be done)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336700
First Posted: June 14, 2006
Last Update Posted: September 19, 2016
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Herbert J. Zeh, III MD, FACS, University of Pittsburgh
June 12, 2006
June 14, 2006
December 23, 2015
September 19, 2016
September 19, 2016
June 2006
October 2011   (Final data collection date for primary outcome measure)
  • 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.
  • 1-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
  • 2-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
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.
Complete list of historical versions of study NCT00336700 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).
  • KRAS Mutational Status [ Time Frame: Up to 60 months ]
    KRAS mutation status in resected tumor specimens.
  • To evaluate overall survival of patients with pancreatic cancer when treated with adjuvant erlotinib and gemcitabine.
  • To evaluate level of expression and mutation of EGFR and its downstream markers on tumor tissue and correlate with patient outcome
  • To evaluate the serum levels of EGFR protein before and after administration of erlotinib and correlate with tumor recurrence and patient survival.
Not Provided
Not Provided
 
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
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
Interventions:
  • Drug: Gemcitabine
  • Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
November 2011
October 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00336700
06-016
Yes
Not Provided
Not Provided
Herbert J. Zeh, III MD, FACS, University of Pittsburgh
Herbert J. Zeh, III MD, FACS
Genentech, Inc.
Principal Investigator: Herb Zeh, M.D. University of Pittsburgh
University of Pittsburgh
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP