Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
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.
|Pancreatic Cancer||Drug: erlotinib hydrochloride Other: immunohistochemistry staining method Other: laboratory biomarker analysis||Phase 2|
|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|
- 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
- Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria [ Time Frame: After every cycle ]
- Median Overall Survival [ Time Frame: After every cycle ]
- 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 ]
- Correlation of Smoking Status With Overall Survival [ Time Frame: Every 3 weeks ]
- 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 ]
|Study Start Date:||January 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
OralOther: immunohistochemistry staining method
Correlative StudyOther: laboratory biomarker analysis
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470535
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Renuka Iyer, MD||Roswell Park Cancer Institute|