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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470535 |
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 |
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Pancreatic Cancer |
Drug: erlotinib hydrochloride Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma |
Estimated Enrollment: | 34 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Renuka Iyer, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Renuka Iyer ) |
Study ID Numbers: | CDR0000543406, RPCI-I-87106 |
Study First Received: | May 3, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00470535 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Erlotinib Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Protein Kinase Inhibitors Recurrence |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Erlotinib Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Pancreatic Neoplasms Endocrine System Diseases Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |