Phase 1/2 Studie:CONKO-008Oxaliplatin/Folinsäure/5-Fluorouracil (24h) in Kombination mit Lapatinib in der Zweitlinientherapie des Pankreaskarzinoms nach Progress unter Gemcitabin-Monotherapie - CONKO-008
- Conditions
- Pancreatic cancer patients who failed first line therapy with gemcitabineMedDRA version: 9.1Level: LLTClassification code 10033604Term: Pancreatic cancer
- Registration Number
- EUCTR2009-009928-37-DE
- Lead Sponsor
- Charite Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 95
- Histologically proven pancreatic adenocarcinoma
- Metastatic disease (phase 2 only)
- Karnowski PI>60
- No other therapy for metastatic pancreatic cancer than Gemcitabine
- Time of progression on Gemcitabine not earlier than 4 weeks before
inclusion
- Measurable disease according to RECIST criteria.
- Normal cardiac function demonstrated by ECG and echocardiogram
(LVEF = 55%)
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Adequate organ function as defined by laboratory values
Hematologic ANC (absolute neutrophil count)
=> 1,5 x 109/L
Hemoglobin => 10 g/dL
Platelets => 100 x 109/L
Hepatic Albumin =>2.5 g/dL
Serum bilirubin <=2 mg/dL/<=3 x ULN (liver metastases)
AST and ALT <=1,5 x ULN without liver metastases
<=5 x ULN if documented liver metastases
RenalSerum Creatinine within range of institution
- OR -
Calculated Creatinine Clearance1 >=60 mL/min
(Calculated by the Cockcroft and Gault Method)
- Patient has provided written informed consent.
- compliance
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
- Insufficient renal/hepatic/bone marrow function
- prior radiation
- prior erlotinib therapy
- secondary malignancies except for basal cell carcinoma of the skin
during the last 5 years
- concomittant diseases which would, to the opinion of the investigator,
endanger study participation
- pregnancy .
- Class II, III or IV heart failure as defined by the NYHA functional
classification system. Myocardial infarction, unstable angina, cardiac
angioplasty or stenting procedure within the last 6 months
- arterial or venous thrombosis, including stroke, transient ischemic
attack, or cerebrovascular accident [CVA] within the last 6 months
- History of malabsorption syndrome, disease significantly affecting
gastrointestinal function or major resection of the stomach or small
bowel that could affect absorption, distribution, metabolism or
excretion of study drugs. Subjects with ulcerative colitis or an
unresolved bowel obstruction are also excluded.
- Concurrent disease or condition that would make the subject
inappropriate for study participation or would interfere with the
subject’s safety.
- Any psychological, familial, or sociological conditions that do not
permit compliance with the protocol.
- Requirement of concurrent cancer therapy (chemotherapy, radiation
therapy, biologic therapy, immunotherapy, or hormonal therapy) while
on study.
- Requirement of concurrent treatment with an investigational agent,
participation in another clinical trial, or any specifically prohibited
medication while on study.
- known immediate or delayed hypersensitivity reaction or idiosyncrasy
to drugs chemically related to Oxaliplatin, 5-FU, Folinic acid or
lapatinib.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase 1: MTD of Tyverb in combination with oxaliplatin, 5-FU and Folinic acid<br><br>Phase 2: Rate of patients with progressive disease after 12 weeks;Secondary Objective: Toxicity, median survival, progression free survival and response rate;Primary end point(s): PhaseI Study<br>Primary endpoint <br>Find the optimal dose of lapatinib in combination with Oxaliplatin/5-FU/Folinic acid (OFF)<br><br>Phase II Study<br>Primary endpoint: <br> Rate of progressive disease after 12 weeks<br>
- Secondary Outcome Measures
Name Time Method