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Erlotinib in Treating Patients With Stage III or Stage IV 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: NCT00470535
Recruitment Status : Terminated (This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib)
First Posted : May 7, 2007
Results First Posted : December 10, 2014
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: erlotinib hydrochloride Other: immunohistochemistry staining method Other: laboratory biomarker analysis Phase 2

Detailed Description:



  • Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.


  • Determine the proportion of patients with a radiological response to this drug.
  • Determine the overall survival of these patients.
  • Determine the effect of this drug on quality of life in these patients.
  • Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in baseline tumor biopsy specimens with response to this drug.
  • Correlate smoking status with PFS in patients treated with this drug.
  • Collect serum samples before, during, and after therapy for future serum proteomic studies and for development of profiles of responders to this drug.

OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire about their smoking status at baseline. Patients also complete questionnaires about their quality of life every three weeks during study therapy and after completion of study therapy.

Blood samples are collected from patients at baseline and periodically during study for future serum proteomic research and for development of profiles of responders to erlotinib hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in patients with prior resection is assessed for K-ras mutations by K-ras analysis.

After completion of study therapy, patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 - Oral Erlotinib hydrochloride
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Drug: erlotinib hydrochloride

Other: immunohistochemistry staining method
Correlative Study

Other: laboratory biomarker analysis
Correlative Study

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Every cycle for up to 52 weeks ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion

Secondary Outcome Measures :
  1. Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria [ Time Frame: After every cycle ]
  2. Median Overall Survival [ Time Frame: After every cycle ]
  3. Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy [ Time Frame: Every 3 weeks ]
  4. Correlation of Smoking Status With Overall Survival [ Time Frame: Every 3 weeks ]
  5. Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade [ Time Frame: At Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Locally advanced inoperable or metastatic disease (stage III or IV disease)
  • No more than 1 prior systemic therapy
  • Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:

    • Ineligible for or refused chemoradiotherapy AND has stage III disease
    • Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease
  • No brain metastases


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • WBC > 3,000/mm³
  • ANC > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Bilirubin ≤ 2 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with documented liver metastases)
  • Creatinine < 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation
  • No known allergy to the study drug or its excipients
  • No symptomatic interstitial pulmonary disease


  • See Disease Characteristics
  • Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry
  • No prior EGFR-inhibitor
  • No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system
  • No concurrent Hypericum perforatum (St. John's wort)
  • No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy

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): NCT00470535

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00470535     History of Changes
Other Study ID Numbers: CDR0000543406
First Posted: May 7, 2007    Key Record Dates
Results First Posted: December 10, 2014
Last Update Posted: February 23, 2017
Last Verified: January 2017
Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action