Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
|ClinicalTrials.gov Identifier: NCT00392665|
Recruitment Status : Terminated (slow accrual)
First Posted : October 26, 2006
Results First Posted : March 14, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck (SCCHN)||Drug: Bevacizumab Drug: erlotinib Drug: Sulindac||Phase 2|
- 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 group.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||October 2006|
|Primary Completion Date :||August 2012|
|Study Completion Date :||December 2013|
Active Comparator: Erlotinib + Bevacizumab
erlotinib plus bevacizumab
Given intravenously on day one of each 3 week cycleDrug: erlotinib
Given orally once a day
Other Name: Tarceva
Active Comparator: Erlotinib + Sulindac
erlotinib plus sulindac
Given orally once a day
Other Name: TarcevaDrug: Sulindac
Given orally twice a day
- Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival. [ Time Frame: 1 year ]The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. 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.
- Overall Response Rate (ORR) [ Time Frame: 2 years ]
Overall response rate (complete plus partial response=ORR), as determined by RECIST.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Duration of Overall Survival [ Time Frame: 2 years ]Median overall survival (OS), determined by the Kaplan-Meier method.
- Number of Participants With Toxicities According to Severity [ Time Frame: 2 years ]Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392665
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute|