A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival

An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival

This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients, >=18 years of age;
• locally advanced and/or metastatic pancreatic cancer (stage III or IV);
• Karnofsky performance Status of >=60%.

Exclusion Criteria:

• local(stage IA to IIB) pancreatic cancer;
• <=6 months since last adjuvant chemotherapy;
• previous systemic therapy for metastatic pancreatic cancer;
• other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
• clinically significant cardiovascular disease.