EUCTR2011-005471-17-DE
Active, not recruiting
Phase 1
Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors
Klinikum der Universität München-Großhadern0 sites150 target enrollmentJanuary 3, 2012
Conditionsmetastatic pancreatic carcinomaMedDRA version: 18.1Level: LLTClassification code 10033576Term: Pancreas carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsTarceva
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- metastatic pancreatic carcinoma
- Sponsor
- Klinikum der Universität München-Großhadern
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically (not cytologically) confirmed metastatic adenocarcinoma of the pancreas (UICC stadium IV; any T, any N, M1 following TNM)
- •\- At least one measurable tumor lesion (CT or MRI) according to RECIST version 1\.1
- •\- ECOG PS 0 and 1
- •\- between 18 and 75 years of age
- •\- bilirubin \= 1\.5 ULN (biliary duct stent in absence of cholangitis is no contraindication)
- •\- availability of tumor samples (no cytological samples)
- •\- written informed consent in collection of tumor\- and blood samples for translational research according to study protocol
- •\- a minimum of 3 month life expectancy
- •\- written informed consent
- •\- a negative pregnancy test result within 7 days prior start of study treatment for women of childbearing potential
Exclusion Criteria
- •\- resectable pancreatic carcinoma
- •\- locally advanced pancreatic carcinoma (non\-resectable tumor without distant metastases)
- •\- prior palliative chemotherapy of the metastatic or locally advanced, non\-resectable pancreatic carcinoma
- •\- prior palliative radiotherapy of the metastatic or locally advanced, non\-resectable pancreatic carcinoma
- •\- radiotherapy within four weeks prior randomization or radiation of target lesions
- •\- adjuvant chemo\- or radiochemotherapy of the pancreatic carcinoma \= six month prior randomisation
- •\- any malignant metastatic disease and any curatively treated neoplasia diagnosed within the last five years prior randomisation
- •\- major surgical intervention within the last two weeks prior randomisation
- •\- chronic diarrhea
- •\- known deficiency of glucuronidation (Gilbert\-Meulengracht syndrome)
Outcomes
Primary Outcomes
Not specified
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