A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00642733
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib [Tarceva] — DRUG
    100mg po daily
  • gemcitabine — DRUG
    1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle

Study Details

This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Key Dates

First listed
Mar 25, 2008
Start date
Aug 31, 2007
Status verified
Aug 2016
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Overall survival; time to progression [ Time Frame: 6 months ]

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