A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
This study will compare the efficacy and safety of escalating versus standard doses to rash
of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer.
During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus
gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not
developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1
will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2
weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other
dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients
will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle.
The anticipated time on study treatment is until disease progression, and the target sample
size is 100-500 individuals.