EUCTR2011-005471-17-DEActive, not recruitingPhase 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 enrollmentStarted: January 3, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- sufficient renal-, liver- and bone marrow function.
- •-- ANC * 1,5 x 109/l
- •-- haemoglobin * 8 g/dl
- •-- thrombocytes * 100 x 109/l
- •-- serum creatinine * 1,25 x ULN
- •-- transaminases * 2,5 x ULN
- •(in case of liver metastases < 5-fach ULN)
- •-- creatinine clearance =30 ml/min
- •- legally competent study participant
- •- ability of regular continuous long-term follow up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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)
- •- acute or subacute ileus or inflammatory bowel disease
- •- pre-existing polyneuropathy > grade 1 regarding NCI-CTCAE v4.0
- •- severe concomitant disease that compromise eligibility and safety of the patient within the study, e.g. active infections or hepatic, renal or metabolic diseases
- •- clinically significant cardiovascular disease within the last twelve month prior randomisation (e.g. instable A. pectoris, myocardial infarction, cardiac insufficiency NYHA = II, arrhythmias requiring treatment)
- •- any psychological, familial, sociological or geographic condition that do not permit adherence to the study protocol
- •- untreated, symptomatic brain metastases (except the patient has undergone successful local therapy of the central brain metastases and no need for treatment with corticosteroids for at least four weeks prior randomisation. Radiological investigations to exclude brain metastases are mandatory only for symptomatic, but not for asymptomatic patients)
- •- known DPD deficiency
- •- concomitant therapy with the virostatics Sorivudin or its chemical relative Brivudin
- •- preganant or breast feeding women; non-effective contraception in men and pre-menopausal women (an effective method of contraception has a Pearl index of < 1)
- •- participation in another study within the last 28 days prior randomisation and during study participation
- •- hypersensitivity to any substance or other components used in this study
- •- former or ongoing keratitis or ulcerative keratitis or existence of severe dryness of the eyes
Investigators
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