Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470535
First received: May 3, 2007
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Every cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response (complete and partial response) as measured by RECIST criteria [ Time Frame: After every cycle ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: After every cycle ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation of smoking status with overall survival [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2007
Study Completion Date: September 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: erlotinib hydrochloride
    Oral
    Other: immunohistochemistry staining method
    Correlative Study
    Other: laboratory biomarker analysis
    Correlative Study
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470535

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470535     History of Changes
Other Study ID Numbers: CDR0000543406, RPCI-I-87106
Study First Received: May 3, 2007
Last Updated: September 23, 2011
Health Authority: United States: Food and Drug Administration

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:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014