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

Not Applicable

Completed

• Conditions: -C25 Malignant neoplasm of pancreas; Malignant neoplasm of pancreas; C25

• Registration Number: PER-110-08
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-17
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients with locally advanced pancreatic cancer, not removable or metastatic, histologically or cytologically confirmed in which the tumor is accessed for biopsy
• Quantifiable disease according to the RECIST criteria (irradiated lesions cannot be used as reference lesions)
• Failure of a previous chemotherapy regimen as a minimum, or patients considered unfit for chemotherapy according to the researchers´ criteria. It should have been> 4 weeks since the last chemotherapy or treatment with another systemic antineoplastic. Patients must have recovered (CTC = 1) from acute toxicities caused by some previous therapy (except alopecia).
• Patients may have received prior radiotherapy for treatment of the local disease, provided that disease progression has been documented, all toxicities have been resolved (CTC = 1) (except for alopecia), and the last radiotherapy fraction is completed at least 4 weeks before randomization.
• Life expectancy> 6 weeks
• Age> 18 years
• Functional status (PS) according to the O-2 ECOG (see section 5.3.2)
• Ability to comply with the protocol
• Written informed consent (signed) by to participate in the study
• The patient must have the will and be able to undergo a biopsy according to their own guidelines and the institution´s requirements for such a procedure.
• Adequate hematological function: ANC = 1.5 x 10 / liter, platelet count = 100 X 10 / liter and Hb = 9 g / dl
• INR = 1.5 and PTT = 1.5 x ULN within 7 days prior to randomization
• Platelet aggregation inhibitors should be discontinued within an appropriate period of time before biopsy
• Adequate liver function: serum bilirubin (total) = 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,
• Albumin> 2.5 g / dl
• Adequate renal function: serum creatinine <1.5 ULN
• In all women of childbearing age, a negative pregnancy test must be obtained within 7 days prior to beginning treatment.

Exclusion Criteria

• Patients with local pancreatic cancer (stage IA to IIB) and excised locally advanced pancreatic cancer.
• Previous treatment with a research or commercialized agent acting on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapies or double TK1 inhibitors
• Any other malignancy that had occurred within the last 5 years prior to randomization, except for properly treated cervical carcinoma in the cervix, basal cell or spinocellular skin cancer
• Evidence of spinal cord compression or current evidence of CNS metastases. A computed tomography / MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of clinical suspicion or evidence of brain metastases
• Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease such as stroke (<6 months before randomization), myocardial infarction (= 6 months before randomization) , unstable angina, CHF> grade 2 according to NYHA, arrhythmia requiring medication, liver, kidney or metabolic disease, metabolic dysfunction), physical examination observation, or clinical laboratory finding that indicates reasonable suspicion of a disease or condition that contraindicates the use of a drug under investigation or that constitutes a high risk of complications related to the treatment for the patient
• Patients who had undergone major surgery within 2 weeks prior to randomization.
• Any known significant ophthalmic abnormality on the surface of the eye (contact lens wear is not recommended)
• Patients who cannot take oral medication, that require intravenous feeding, who have malabsorption syndrome or any other condition that affects gastrointestinal absorption, or who have active peptic ulcer
• Pregnant or breastfeeding women
• Men and women of childbearing age (<2 years after the last menstrual period) who are not using an effective contraceptive method (eg, oral contraceptives, intrauterine device, sexual abstinence or surgical sterilization), having a rate of effectiveness as a value of failure <1% / year.
• Current or recent treatment (within 30 days prior to beginning the study treatment) with another investigational drug or participation in another research study
• Patients with known positive HIV. No analysis is required in the absence of clinical signs and symptoms that suggest HIV infection.
• Known hypersensitivity to any of the study drugs or their excipients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified