A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
NCT00642733 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2016-08-24
Summary
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.
Conditions
Interventions
- DRUG
-
erlotinib [Tarceva]
100mg po daily
- DRUG
-
1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2009-04-30
- Completion
- 2009-04-30
Countries
- Mexico
Study Locations
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