Overview

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.