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

ROCHE0 sites200 target enrollmentMarch 20, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 20, 2008

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Disease specific inclusion criteria:
•1\. Histologically or cytologically confirmed locally advanced\-unresectable or metastatic
•pancreatic cancer where tumor is accessible for biopsy
•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. There must be \> 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 weeks
•General inclusion criteria:

•Disease specific exclusion criteria:
•1\. Local (Stage IA to IIB) pancreatic cancer and locally advanced\-resectable pancreatic cancer.
•2\. Prior treatment with an investigational or marketed agent which acts on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti\-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors
•3\. Any other malignancies within the last 5 years before randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
•4\. Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 4 weeks before randomization) in case of clinical suspicion or evidence of brain metastases
•General exclusion criteria
•5\. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (\< 6
•months before randomization), myocardial infarction (\< 6 months before randomization), unstable angina, NYHA \> grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease, metabolic dysfunction), physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra\-indicates the use of an investigational drug or puts the
•patient at high risk for treatment\-related complications