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

F. Hoffmann-La Roche0 sites200 target enrollmentMay 12, 2008

ConditionsPancreatic cancer MedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastatic MedDRA version: 9.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectable

DrugsTarceva

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pancreatic cancer
Sponsor: F. Hoffmann-La Roche
Enrollment: 200
Status: Active, Not Recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2008

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche

Eligibility Criteria

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\.3\.2\)
•8\. Able to comply with the protocol
•9\. Written (signed) Informed Consent to participate in the study
•10\. Patient must be willing and able to undergo biopsy according to the institute’s own guidelines and requirements for such procedures.

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 study start, 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 study start) in case of clinical suspicion or evidence of brain metastases
•5\. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (\<\= 6 months before study start), myocardial infarction (\<\= 6 months before study start), 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
•6\. Patients who have had any major surgery within 2 weeks prior to study start
•7\. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
•8\. Patients unable to take oral medication, requiring intravenous alimentation, who have mal\-absorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease
•9\. Pregnant or lactating females
•10\. Men and women of childbearing potential (\<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile)