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

Unknown Primary Tumors Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Unknown Primary
• Unknown Primary Tumors

• NCT number: NCT00458315
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2007
• Completion date: May 2012