A phase II Biomarker Identification Trial for Erlotinib (Tarceva) in Patients with Advanced Pancreatic Carcinoma. - ND
- Conditions
- -C25 Malignant neoplasm of pancreasMalignant neoplasm of pancreasC25
- Registration Number
- PER-110-08
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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
- Primary Outcome Measures
Name Time Method <br>Outcome name:Defined as the period between randomization and the first occurrence of progressive disease (PD) or death from any cause, whichever comes first. Patients without events will be counted at the date of the last evaluation of the tumor when the absence of progression is documented.<br>Measure:Progression Free Survival (PFS)<br>Timepoints:the period between randomization and the first occurrence of progressive disease<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The respondent is defined as the patient who is maintained with a response of the category Complete response (CR) or Partial response (PR) for at least 4 weeks at any time during randomized treatment (confirmed response). Otherwise, the patient is defined as not responding.<br>Measure:Response rate<br>Timepoints:4 weeks<br>;<br>Outcome name:A patient achieved control of the disease if he is a responder or if he has stable disease for at least 6 weeks after randomization. Otherwise, the patient failed to control the disease.<br>Measure:Disease control rate<br>Timepoints:6 weeks<br>;<br>Outcome name:Overall survival is defined as the period of time from the date of randomization to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis will be censored on the date it was last known that the patient was alive.<br>Measure:Global survival<br>Timepoints:from the date of randomization to the date of death<br>