A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARK

INTERVENTION: Trade Name: Tarceva Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Erlotinib CAS Number: 183321‐74‐6 Current Sponsor code: Ro 50‐8231 Other descriptive name: erlotinib hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Tarceva Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Erlotinib CAS Number: 183321‐74‐6 Current Sponsor code: Ro 50‐8231 Other descriptive name: erlotinib hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Tarceva Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Erlotinib CAS Number: 183321‐74‐6 Current Sponsor code: Ro 50‐8231 Other descriptive name: erlotinib hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Pancreatic cancer ; MedDRA version: 9.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic ; MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non‐resectable PRIMARY OUTCOME: Main Objective: Identification of biomarker(s) which may predict improvement in progression free survival from treatment with erlotinib Primary end point(s): ‐ Assessment of EGFR expression and gene copy number in tumor tissue; ‐ Assessment of HER2 and HER3 expression in tumor tissue; ‐ Assessment k‐RAS mutation status in tumor tissue; ‐ Assessment of EGFR ligands in serum and tissue; ‐ EGFR Intron 1 polymorphism in blood; Secondary Objective: Assessment of efficacy and safety INCLUSION CRITERIA: 1. Histologically or cytologically confirmed locally advanced‐unresectable or metastatic pancreatic cancer 2. Measurable disease according to RECIST (irradiated lesions can not be used as target lesions) 3. Failure of at least one prior chemotherapy regimen or patients who are deemed unsuitable for chemotherapy in the investigators opinion. >= 4 weeks since last chemotherapy or treatment with another systemic anti‐cancer agent. Patients must have recovered (CTC <= 1) from acute toxicities of any previous therapy (with the exception of alopecia). 4. Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC <= 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to randomization. 5. Life expectancy of = 6 week 6. Age >= 18 years 7. ECOG performance status of 0 ‐ 1 (see section 5