Head And Neck Cancer Clinical Trial
Official title:
Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
The goal of this clinical research study is to learn if RAD001 in combination with Tarceva (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The safety of this drug combination will also be studied.
The Study Drugs: RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, and this may cause the tumor cells to die. Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing. Study Drug Administration: If you are found to be eligible to take part in this study, you will take 1 RAD001 tablet and 1 erlotinib hydrochloride tablet every day of each 28 day study "cycle". Both drugs should be taken at the same time, by mouth, with a cup (8 ounces) of water. You should take the drugs at least 1 hour before or 2 hours after eating. You should take the study drugs at around the same time each day. Your eating habits around the time you take the drugs should stay the same while you are on study. lf you vomit, you should not take another tablet until your next scheduled dose. Tell your doctor if you have any side effects, as your dose(s) of study drug(s) may be lowered or stopped for a few days. You may be given drugs to help reduce the risk of side effects. Study Visits: On Day 1 (+/- 3 days) of each cycle, the following tests and procedures will be performed: - You will have a complete physical exam, including measurement of your weight and vital signs. - You will be asked about any drugs you may be taking and any side effects you may be having. - Your performance status will be recorded. - Blood (about 3 teaspoons) will be drawn for routine tests. If your doctor thinks it is needed, you may have to have these blood tests more often. On Day 1 (+/- 3 days) of every evenly numbered cycle (Cycles 2, 4, 6, and so on), you will have a CT scan or MRI scan to check the status of the disease. Length of Study: You may continue to take the study drugs for as long as you are benefitting. You will be taken off study if the disease gets worse or if you have intolerable side effects. End-of-Study Visit: When you go off study for any reason, you will have an end-of-study visit. The following tests and procedures will be performed: - Your medical history will be recorded. - You will have a complete physical exam, including measurement of your weight and vital signs. - You will be asked about any drugs you may be taking and any side effects you may be having. - Your performance status will be recorded. - Blood (about 3 teaspoons) will be drawn for routine tests. - You will have a CT scan or MRI scan to check the status of the disease. Follow-Up: You will be called within 30 days after the end-of-study visit and asked how you are doing and about any possible side effects that you may have had. The call should take about 5 minutes. This is an investigational study. RAD001 is FDA approved and commercially available for the treatment of certain types of breast cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of advanced non-small cell lung carcinoma (NSCLC) and advanced pancreatic cancer. The use of this drug combination for the treatment of HNSCC is investigational. Up to 35 patients will take part in this study. All will be enrolled at MD Anderson. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |