Squamous Cell Carcinoma of the Head and Neck (SCCHN) Clinical Trial
Official title:
Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
The main purpose of this research study is to collect information to learn how effective erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR), and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The bevacizumab being administered in this study is not a commercially marketed formulation of the drug. Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity. This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer.
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01204099 -
Study of PX-866 and Docetaxel in Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02499120 -
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04989387 -
Study of INCA 0186 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT05057247 -
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
|
Phase 2 | |
Completed |
NCT02001623 -
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01285635 -
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck
|
Phase 2 | |
Completed |
NCT03538028 -
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT02335918 -
A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT04052204 -
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03405142 -
Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
|
Phase 2 |