NCT00894569

Paclitaxel/Carboplatin With or Without Cetuximab in CUP

Open-Labeled, Randomized Multi-Center Phase II Study Evaluating the Efficacy and Safety of Paclitaxel/ Carboplatin With and Without Cetuximab as First-Line Treatment of Adeno- and Undifferentiated Carcinoma of Unknown Primary (CUP)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary.

Detailed description

Carcinomas of unknown primary (CUP) account for approximately 2-5% of all cancer diagnoses. Except for some subsets with favorable prognosis, for most of these patients, treatment options are limited, and no standard first-line regimen has been identified. Standard therapy for patients with adeno- or undifferentiated CUP is Paclitaxel/Carboplatin, yielding response rates between 20-40%. In recent years, targeted therapies with inhibitors to EGFR, several tyrosine kinases, and VEGF have been shown to improve survival in different solid tumor entities. Cetuximab, a monoclonal antibody against the EGF receptor, has proved efficacy in combination with chemotherapy in patients with metastatic colorectal cancer, gastric cancer, squamous cell carcinoma of head and neck and non-small cell lung cancer (NSCLC). Because of these promising results it seems to be reasonable to examine the impact of adding cetuximab to standard chemotherapy with paclitaxel and carboplatin in patients with CUP.

Conditions

• Neoplasms, Unknown Primary
• Carcinoma

Interventions

Type	Name	Description
DRUG	paclitaxel/carboplatin	6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
DRUG	cetuximab	cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• Completion: 2011-08-01
• First posted: 2009-05-07
• Last updated: 2009-05-14

Locations

1 site across 1 country: Germany