PER-110-08
Completed
未知
A phase II Biomarker Identification Trial for Erlotinib (Tarceva) in Patients with Advanced Pancreatic Carcinoma. - ND
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C25 Malignant neoplasm of pancreas
- Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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