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)
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
8 months after randomization
Alwin Kraemer, Prof. Dr.
University of Heidelberg, Medic. Dep. V