Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1 - Oral Erlotinib hydrochloride
Arm Description
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
Outcomes
Primary Outcome Measures
Progression-free Survival
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
Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria
Median Overall Survival
Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy
Correlation of Smoking Status With Overall Survival
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
Full Information
NCT ID
NCT00470535
First Posted
May 3, 2007
Last Updated
January 9, 2017
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00470535
Brief Title
Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Official Title
Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Oral Erlotinib hydrochloride
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Description
Correlative Study
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative Study
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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
Time Frame
Every cycle for up to 52 weeks
Secondary Outcome Measure Information:
Title
Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria
Time Frame
After every cycle
Title
Median Overall Survival
Time Frame
After every cycle
Title
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
Title
Correlation of Smoking Status With Overall Survival
Time Frame
Every 3 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renuka Iyer, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
12. IPD Sharing Statement
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Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
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