EUCTR2005-004605-29-IT
Active, not recruiting
Not Applicable
A Phase IIIb Study of Tarceva (Erlotinib) in patients with locally advanced, unresectable or metastatic pancreatic cancer - TARCEVA - EAP in pancreatic carcinoma
Conditionsocally advanced, unresectable or metastatic pancreatic cancer (adenocarcinoma)MedDRA version: 14.1Level: PTClassification code 10033610Term: Pancreatic carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsTarceva
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ROCHE
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 \<5 ULN in case of liver metastases). \- Serum creatinine \< 1\.5 ULN or creatinine clearance \> 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
- •\- 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.
Investigators
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