NCT00360360

Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.

Detailed description

All eligible patients will receive: * Bevacizumab 15mg/kg IV infusion,Day 1 * Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 * Carboplatin AUC 6.0 IV Day 1 * Erlotinib 150 mg by mouth daily The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

Conditions

• Neoplasm, Unknown Primary

Interventions

Type	Name	Description
DRUG	paclitaxel	Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
DRUG	carboplatin	Carboplatin AUC 6.0 IV Day 1
DRUG	bevacizumab	Bevacizumab 15mg/kg IV infusion,Day 1
DRUG	erlotinib	Erlotinib 150 mg by mouth daily

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-02-01
• Completion: 2009-03-01
• First posted: 2006-08-04
• Last updated: 2013-12-04
• Results posted: 2013-10-21

Locations

9 sites across 1 country: United States