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A Randomized, Double-Blind, Placebo-Controlled Study Of Chemotherapy Plus Cetuximab In Combination With VTX- 2337 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck.
Protocol Number:
Phase II
Hyunseok Kang
To compare the disease response, safety, and survival of patients treated with the standard of care regimen of cisplatin or carboplatin + 5FU + cetuximab in combination with VTX-2337 to those treated with the standard of care regimen alone.
-confirmed squamous cell cancer of the head and neck -locoregionally recurrent or metastatic disease -measurable disease on CT or MRI scan -good physical condition with good blood counts and organ function -no prior systemic anti-cancer therapy unless administered for locally advanced disease and completed at least 6 months prior to start -no surgery, radiation, immunotherapy, or investigational agents within 4 weeks -no active autoimmune disease or known infection with HIV -no treatment with steroids with 2 weeks -no significant heart disease within 6 months prior to start -nasopharyngeal, salivary gland, lip, and sinonasal cancers are not allowed
Standard of care regimen is given every 21 days for a maximum 6 cycles and consists of the following: Cisplatin or Carboplatin given IV on Day 1 of each cycle. 5FU given as a continuous IV infusion via portable pump, on Days 1-4 of each cycle. Cetuximab given IV weekly. Patents will be randomized to receive VTX-2337 or Placebo given as a subcutaneous injection on Day 8 and Day 15 of each 21 day cycle. Following 6 cycles of combination therapy, VTX-2337 or Placebo given as a subcutaneous injection, will be given on Day 8 and Day 22 every 28 days starting with Cycle 7 and continuing until disease progression.
Last Update
10/30/2014 04:03 AM

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