A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
- Registration Number
- NCT00642733
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- adult patients, >=18 years of age;
- pancreatic cancer, surgically unresectable or with metastases;
- no previous chemotherapy (except concomitant with radiotherapy);
- ECOG 0-2.
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Exclusion Criteria
- pancreatic cancer without histologic or cytologic confirmation;
- surgical resection possible;
- previous chemotherapy not concomitant with radiotherapy;
- ECOG 3-4.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 erlotinib [Tarceva] - 1 gemcitabine -
- Primary Outcome Measures
Name Time Method Overall survival; time to progression 6 months
- Secondary Outcome Measures
Name Time Method Duration of response; disease-free survival Event driven AEs, lab parameters Throughout study