Clinical Trial: Paclitaxel/Carboplatin With or Without Cetuximab in CUP

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Car

Brief 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 Summary: 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.
Sponsor: Heidelberg University

Current Primary Outcome: The rate of progression free survival at 8 months after randomization, defined as the proportion of patients alive with stable disease, partial or complete response, according to RECIST is the primary endpoint for the final analysis. [ Time Frame: 8 months after randomization ]

Original Primary Outcome:

Current Secondary Outcome: Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity [ Time Frame: until end of study ]

Original Secondary Outcome:

Information By: Heidelberg University

Dates:
Date Received: May 6, 2009
Date Started: July 2009
Date Completion: August 2011
Last Updated: May 13, 2009
Last Verified: May 2009