Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00470535

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 Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response (complete and partial response) as measured by RECIST criteria [ Designated as safety issue: No ]
Median overall survival [ 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 [ Designated as safety issue: No ]
Correlation of smoking status with overall survival [ 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 [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	January 2007
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

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

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

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Renuka Iyer, MD

Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Roswell Park Cancer Institute ( Renuka Iyer )
Study ID Numbers:	CDR0000543406, RPCI-I-87106
Study First Received:	May 3, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00470535
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:

Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009