pancreatic cancer adjuvant therapy after R0-resection Gemcitabine plus Erlotinib vs. Gemcitabine mono, given over 24 weeks randomised trial
Conditions
Interventions
Trade Name: Tarceva
Product Name: Erlotinib
Product Code: n/a L01XX34
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Erlotinib
Other descriptive name: Tarceva
Concentration unit: mg milligram
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: R0-resection histologically confirmed diagnosis of an adenocarcinoma of the pancreas no previous neoadjuvant anticancer treatment karnofsky performance status > = 60% patient compliance signed informed consent sufficient blood cell count age > = 18 years beginning of the chemotherapy between week 2-8 post OP, wound healing must be completed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other serious illness: uncontrolled hypertension, congestive heart failure (NYHA III-IV), symptomatically coronary heart disease, uncontrolled cardial arrythmia > grade 2, occlusive periphere arterial disease > stage IIb other serious illness with life expectancy grade 2 NCI-CTCAE v3.0 impaired renal or liver function postoperative mesurable tumorlesion pregnant or braestfeeding patients. Woman of childbearing potential must have a negative pregnancy test performewd 7 days prior to start of the traetment sexually active males and females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 month after end of study medication known allergic reactions against the study drugs or the substances included therein patients undergoing renal dialysis interstitial pneumonia or symptomatic fibrosis of the lung immuno-suppressive therapy (e.g. allogeneic transplantation) severe non-healing wounds, ulcers or bone fractions enrollment in another clinical trial previous or ongoing narcotic drug, medication or alcohol abuse patients which are not able to take in oral drugs, need parenteral nutrition, are known to have an insufficient gastrointestinal resorption or suffer from acute stomach ulcer other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the disease free survival in both treatment groups;Secondary Objective: to compare the overall survival in both treatment groups, toxicity;Primary end point(s): to compare diseasde free survival in both treatment groups relapse of the pancreatic cancer | — |
Countries
Germany
Outcome results
None listed