Conditions: Neoplasm, Unknown Primary
Keywords: Neoplasm, Unknown Primary
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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

Interventions: intervention 1: paclitaxel intervention 2: carboplatin intervention 3: bevacizumab intervention 4: erlotinib
Intervention descriptions: intervention 1: Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 intervention 2: Carboplatin AUC 6.0 IV Day 1 intervention 3: Bevacizumab 15mg/kg IV infusion,Day 1 intervention 4: Erlotinib 150 mg by mouth daily

Protocol document: