NCT00458315

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unknown Primary Tumors

Interventions

Type	Name	Description
DRUG	Cisplatin
DRUG	Paclitaxel
DRUG	Gemcitabine
DRUG	Avastin (Bevacizumab)

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-08-01
• Completion: 2012-05-01
• First posted: 2007-04-10
• Last updated: 2015-05-08

Locations

1 site across 1 country: Denmark