A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer - Full Text View

Purpose

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: erlotinib [Tarceva] Drug: placebo	Phase II

MedlinePlus related topics:

Cancer Pancreatic Cancer

Drug Information available for:

Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

EGFR expression and gene copy number, HER2, HER3 expression and k-RAS mutation status in tumor tissue, EGFR ligands in serum [ Time Frame: At screening ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate, disease control rate and overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse events, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib [Tarceva] 150mg po daily
2: Placebo Comparator	Drug: placebo po daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
measurable disease according to RECIST;
failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
ECOG performance status of 0-2.

Exclusion Criteria:

local or locally advanced-resectable pancreatic cancer;
any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
major surgery within 2 weeks prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674973

Contacts


Contact: Please reference Study ID Number: PDO_BO21129	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Show 79 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO21129, 2007-003738-40
First Received:	April 30, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00674973
Health Authority:	Malaysia: Ministry of Health

Study placed in the following topic categories:

Erlotinib

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Disease Progression

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

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 October 23, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00674973