Spots Global Cancer Trial Database for Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor

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Trial Identification

Brief Title: Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor

Official Title: Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors

Study ID: NCT00458315

Conditions

Unknown Primary Tumors

Interventions

Cisplatin

Paclitaxel

Gemcitabine

Avastin (Bevacizumab)

Study Description

Brief Summary: The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

Detailed Description: Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: Arm A: Cisplatin, Paclitaxel and Gemcitabine * Cisplatin 75 mg/m2 IV infusion, Day 1 * Paclitaxel 175 mg/m2 IV infusion, Day 1 * Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8 Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab) * Cisplatin 75 mg/m2 IV infusion, Day 1 * Paclitaxel 175 mg/m2 IV infusion, Day 1 * Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8 * Bevacizumab 7,5 mg/m2 IV infusion, Day 1 Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high). The regimens will be repeated every 21 days.