poor recruitment

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.

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.

Exclusion Criteria:

• pancreatic cancer without histologic or cytologic confirmation;
• surgical resection possible;
• previous chemotherapy not concomitant with radiotherapy;
• ECOG 3-4.