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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Pancrelipase

Criteria

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.