Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
- Participants will be randomized to either Arm A: erlotinib plus bevacizumab, or Arm B:
erlotinib plus sulindac. Participants will have an equal chance of being placed in any
- Medication on Arm A: erlotinib plus bevacizumab: Participants will take erlotinib
pills orally once a day. Bevacizumab will be given intravenously on day one of each
treatment cycle (each treatment cycle will last three weeks). Urine tests will be
performed once every three weeks to test kidney function.
- Medication on Arm B: erlotinib plus sulindac: Participants will take erlotinib pills
orally once a day. Sulindac will be taken orally twice a day.
- Physical exams will be performed during each treatment cycle and will include vital
signs and general health questions. We will take the participants blood pressure every
2 weeks for the first 6 weeks. After that point, we will take it every 3 weeks or more
often if necessary. Blood tests will be performed including chemistry and hematology.
- After every 2 cycles, a repeat CT scan, MRI, and/or PET scan will be performed along
with either a chest x-ray or CT scan to ensure that there is no tumor in the
participants lungs. We may also do a bone scan if there may be tumor in the
participants bones, and abdominal CT scan if there may be tumor in the liver, and a
head CT scan or MRI if there may be tumor in the brain.
- After the final treatment the participant will be seen in the clinic to see if they
have had any side effects from the drugs within 30 days of stopping the drugs.
- Participants will be in this research study for as long as they are receiving clinical
benefits from the study drugs, and do not develop excessive side effects or disease
progression. After treatment is discontinued, we will follow the participant closely
for 30 days and every 1-2 months after that.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of erlotinib plus bevacizumab (Arm A) or erlotinib plus sulindac (Arm B) in subjects with incurable recurrent and/or metastatic squamous cell carcinoma of the head and neck as measured by progression-free survival.
Jochen Lorch, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|