A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
- ECOG performance status of 0-1.
Exclusion Criteria:
- local, or locally advanced, pancreatic cancer;
- prior systemic treatment for metastatic pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Gemcitabine, Erlotinib Standard Dose
Gemcitabine, Erlotinib Escalating Dose
Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.