Locally advanced, unresectable or metastatic pancreatic cancer (adenocarcinoma) MedDRA version: 14.1 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Erlotinib
Concentration unit: mg milligram(s)
Concentration number: 100-
Trade Name: Tarceva
Pharmaceutical Form: Film
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed pancreatic cancer (adenocarcinoma), with measurable or non measurable locally advanced, unresectable (stage III) or metastatic pancreatic cancer (stage IV) disease (according to TNM 6th edition). - No prior systemic treatment for metastatic pancreatic cancer is allowed. Radiotherapy (adjuvant setting with ≤ 350 mg/m2/week gemcitabine) is allowed if progressive lesion(s) present outside the irradiated port. All adjuvant therapy will have been given at least 6 months prior to study entry and patients must have fully recovered from their adjuvant therapy toxicity. - Age ≥ 18 years - ECOG performance status of 0 - 3 - Life expectancy of at least 12 weeks - Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L - Serum (total) bilirubin ≤ 1.5 x ULN, AST & ALT ≤ 2.5 x ULN ( ≤ 5 x ULN in patients with liver metastases) - Alk Phos ≤ 2.5 ULN. If Alk Phos is ≥ 2.5 ULN, SGOT (AST) and SGPT (ALT) must be ≤ 1.5 ULN (or 60 ml/min - Able to comply with study and follow-up procedures - For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. - Patients with reproductive potential must use effective contraception - Written (signed) Informed Consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 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
Exclusion criteria: - Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease). - Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy). - Any other malignancies within 5 years that to the clinician s opinion may affect therapy outcome results - Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. - Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. - Nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected Tarceva related AEs and Tarceva related rash.;Secondary Objective: - Quality of life; - Efficacy of Tarceva as measured by Overall Survival and Progression Free Survival (PFS).;Primary end point(s): Safety; efficacy; quality of life. | — |
Countries
Italy
Outcome results
None listed