Patients with unresectable advanced or metastatic pancreatic cancer MedDRA version: 6.1 Level: PT Classification code 10033609
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Other antineoplastic agents
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed unresectable advanced or metastatic pancreatic adenocarcinoma - Measurable or evaluable disease. To be considered evaluable for complete or partial response patients must have at least one measurable lesion. - age 18-70 yrs - PS 0-1 (ECOG scale) - No previous chemotherapy for advanced/metastatic pancreatic carcinoma. Previous adjuvant treatment is allowed. - Patients must have no uncontrolled concurrent serious medical illness. - Investigations including chest x-ray, CT scan of abdomen and pelvis and other scans (as clinically indicated), have to be performed within 28 days prior to start the treatment. - Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to start the treatment: ANC > 1500/l PLT > 100000/l Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - history of malignancies in the last 5 years - significant history of cardiac disease, uncontrolled high blood pressure, instable angina, congestive heart failure, myocardial infarction within the last year. - Serious active infection or serious underling medical conditions - Known CNS metastases. CT scan of brain is not required unless there is clinical suspicion of CNS involvement - GI tract disease resulting in an inability to take oral medication or a requirement of IV alimentation, prior surgery procedure affecting absorption, uncontrolled inflammatory GI disease - Serious active infection or serious underlying medical conditions that would impair the ability of the patient to receive the treatment. - Prior treatment with inhibitors of EGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and the toxicity of increasing doses of Gemcitabine given as fixed dose rate infusion of 10 mg/m2/min every 2 weeks in combination with Erlotinib.;Secondary Objective: - Activity of the treatment in terms of objective response rate (partial response and complete response) - Efficacy: progression-free and overall survival;Primary end point(s): Primary - MTD of Gemcitabine given as fixed dose rate infusion given in combination with Erlotinib Biological - When tumor tissue available before and after at least 4 courses of treatment: EGFR, EGFR gene copy number (FISH), p-EGFR, p-MAPK, p-Akt, p21, EGFR mutation (exons 18, 19, 21), VEGFR | — |
Countries
Italy
Outcome results
None listed