The trial will evaluate a sequential chemotherapy in patient suffering from metastatic pancreatic carcinoma which had not been treated in the past. MedDRA version: 8.1 Level: LLT Classification code 10033610 Term: Pancreatic carcinoma metastatic
Conditions
Interventions
Trade Name: CAMPTO
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Current Sponsor code: CPT-11
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Ageo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pathologically proven pancreatic adenocarcinoma (on primitive or metastatic lesion) - Age between 18 and 75 years - Life expectancy >12 weeks - Performance status OMS =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - No prior chemotherapy (except adjuvante chemotherapy with gemcitabine realised more than 12 months before inclusion day) - No prior radiation therapy (except if there is at least one mesurable target outside irradiation area) - Known brain metastasis (no need of systematic CTscan) - Pregnant or feeding woman - Previous carcinoma within the last 5 years (except basal cell carcinoma and in situ carcinoma cervix) - Concomitant antitumoral treatment - Recent (within 30 days prior inclusion) participation in another investigational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 6 months progression free survival rate ;Secondary Objective: - Objective response rate - Time to treatment failure - Overall survival - Tolerance - Clinical benefit / Quality of life (Time to definitive Global health score deterioration) ;Primary end point(s): the primary end point of this phase II study is progression free survival at 6 months. | — |
Countries
France
Outcome results
None listed