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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
Carboplatin AUC 6.0 IV Day 1
Bevacizumab 15mg/kg IV infusion,Day 1
Erlotinib 150 mg by mouth daily
Integrated Community Oncology Network
Jacksonville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 18 months
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