Conditions: Cancer
Keywords: head neck
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.

Detailed description:
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.

Arms:
arm 1: None

Interventions: intervention 1: Pemetrexed intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 500 mg/m2 day 1 q 21 days intervention 2: 15 mg/kg IV q 21 days following pemetrexed

Protocol document: