A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Tracking Information

Start Date  ICMJE 
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: May 7, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00674973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 7, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Official Title  ICMJEA Randomized, Double Blind Study of Biomarkers Predictive of Improvement in Progression Free Survival in Patients With Advanced Pancreatic Cancer Treated With Tarceva.
Brief Summary

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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPancreatic Cancer
Intervention  ICMJE
  • Drug: erlotinib [Tarceva]
    150mg po daily
  • Drug: placebo
    po daily
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: erlotinib [Tarceva]
  • 2: Placebo Comparator
    Intervention: Drug: placebo

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE252
Estimated Completion DateSeptember 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO21129973-235-5000
Contact: or800-526-6367 (FOR US ONLY)
Location Countries  ICMJEArgentina,   Australia,   Brazil,   Bulgaria,   Croatia,   France,   Germany,   Hong Kong,   India,   Italy,   Latvia,   Lithuania,   Malaysia,   Mexico,   Peru,   Romania,   Russian Federation,   Singapore,   Slovenia,   Ukraine,   United Kingdom

Administrative Information

Responsible PartyClinical Trials, Study Director, Hoffmann-La Roche
Study ID Numbers  ICMJEBO21129, 2007-003738-40
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche, +1 973 235 5000
Information Provided ByHoffmann-La Roche