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

Conditions: Advanced Pancreatic carcinoma
MedDRA version: 9.1Level: HLTClassification code 10033633Term: Pancreatic neoplasms malignant (excl islet cell and carcinoid)

Registration Number: EUCTR2007-003738-40-IT

Lead Sponsor: ROCHE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

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:
6. Age > 18 years
7. ECOG performance status of 0 - 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.
11. Adequate hematological function: ANC > 1.5 x 109/L, platelet count > 100 x 109/L and Hb > 9 g/dL
12. INR < 1.5 and PTT < 1.5 x ULN within 7 days prior to randomization
13. Platelet aggregation inhibitors must be discontinued within an appropriate time period before biopsy
14. Adequate liver function: Serum (total) bilirubin < 1.5 x ULN, SGOT (AST) and SGPT (ALT) < 2.5 x ULN in the absence of liver metastases or up to 5 x ULN for SGOT (AST) and SGPT (ALT) in case of liver metastases,
15. Albumin > 2.5 g/dL
16. Adequate renal function: serum creatinine < 1.5 ULN
17. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion 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

Etc.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Sopravvivenza libera da progressione;Secondary Objective: Overall survival<br> Response rate<br> Disease control rate<br> Safety;Main Objective: Identification of biomarker(s) which may predict improvement in PFS from treatment with erlotinib.

Secondary Outcome Measures