Neoplasm, Unknown Primary Clinical Trial
Official title:
A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment