Randomized fase II trial: comparing Cisplatin, Paclitaxel and Gemcitabine vs. Cisplatin, Paclitaxel, Gemcitabine and Avastin in patients with unknown primary tumors

INTERVENTION: Trade Name: Cisplatin Product Name: Cisplatin Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CISPLATIN CAS Number: 15663271 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50, 100‐ Trade Name: Paclitaxel Product Name: Paclitaxel Pharmaceutical Form: Intravenous infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069624 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30, 100, 300‐ Trade Name: Gemzar Product Name: Gemcitabine Pharmaceutical Form: Intravenous infusion INN or Proposed INN: GEMCITABINE HYDROCHLORIDE CAS Number: 122111039 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200, 1000‐ Trade Name: Avastin Product Name: Bevacizumab Pharmaceutical Form: Intravenous infusion Other descriptive name: BEVACIZUMABUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100, 400‐ CONDITION: To test in a randomized fase II trial the effect of Cisplatin, Paclitaxel, Gemcitabine +/‐ Avastin in patients with unknown primary tumors between the age of 18 and 70 years old and with a perfomance status 0‐1 PRIMARY OUTCOME: Main Objective: 1. Response rate; 2. Progression free survival Primary end point(s): Response rate; Progression free survival Secondary Objective: 1. Toxicity; 2. Survival; 3. Response duration INCLUSION CRITERIA: unknown primary tumor Performance status 0‐1 Age between 18 and 70 years old Measurable lesion by RECIST Life expectancy > 3 months Sufficient organ functions 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