A Phase 2 interventional study of paclitaxel/carboplatin and cetuximab in Neoplasms, Unknown Primary and Carcinoma, sponsored by Heidelberg University. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-14.
Sponsored by Heidelberg University · Phase 2, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 150 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow function:
Adequate liver and renal function:
Exclusion Criteria:
6 cycles of carboplatin/paclitaxel
Drug: paclitaxel/carboplatin
carboplatin/paclitaxel plus cetuximab until disease progression
Drug: paclitaxel/carboplatin · Drug: cetuximab
6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression
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
Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity
Time frame: until end of study
This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Heidelberg University