Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Every cycle
Safety Issue:
No
Principal Investigator
Renuka Iyer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000543406
NCT ID:
NCT00470535
Start Date:
January 2007
Completion Date:
September 2010
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- recurrent pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
