A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Rash, Grade <2
Rash, Grade ≥2
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.