Head and Neck Cancer Clinical Trial
Official title:
Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers
The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
Background Head and neck squamous cell carcinoma (HNSCC) constitutes 3% of all malignancies
and is the sixth most common malignancy worldwide. There will be an estimated 40,000 new
cases and 11,000 deaths in the United States in 2007 and approximately 500,000 cases
worldwide yearly [1]. Squamous cell carcinoma accounts for at least 90% of all head and neck
cancers. Surgical resection remains a standard treatment for patients with resectable HNSCC.
For patients with high risk of local or distant relapse, radiation therapy (RT) alone, or in
combination with chemotherapy, is given after surgery to improve loco-regional control and
overall survival. Moreover, surgery often represents the only curative option in patients
who relapse locoregionally. Non-small cell lung cancer (NSCLC) is the leading cause of death
worldwide. NSCLC is infrequently diagnosed when the cancer can be eradicated with surgical
extirpation.
Specific Aims
- To determine the modulation of biomarkers by EGFR and/or Src targeting in head and neck
and lung cancers.
- To determine if biomarker modulation is associated with reduction of tumor volume
and/or evidence of histologic response in the tumor (e.g. decreased proliferation
and/or decreased apoptosis) as well as safety and tolerability.
Subject population Patients will be accrued from head and neck and lung cancer patients who
are surgical candidates. Surgery will be the primary curative treatment for patients
enrolled in this study. Patients should not require any standard induction treatment prior
to surgery. Surgery will have to be the best treatment option as determined by the treating
physician. Therefore, we will not be delaying chemoradiotherapy or other curative treatment.
We plan to include any stage of HNSCC or NSCLC that will be managed by primary surgery. If
surgery is unexpectedly cancelled, the patient will be removed from the study unless there
is an accessible lesion for biopsy. Ideally, the pre-treatment biopsy and the intraoperative
sample will be obtained from the same site (when there are multiple lesions). Please see
Section 3.0 for detailed eligibility criteria.
Treatment Plan The study drug or placebo will be taken for 14-21 days, and will be
discontinued one day prior to planned surgical resection. If surgery is delayed, the study
drug or placebo will be continued until one day prior to surgery, for up to a maximum of 28
days. Seven days is the minimum treatment for the patients to be evaluated. The interval
between the last dose of experimental drug and surgery will be 12-36 hours. Please see
Section 5.0 for treatment plan details. If the combination of erlotinib and dasatinib
results in toxicity leading to a delay in surgery, the study will be terminated.
Statistical design and sample size This is a 4-arm randomized trial that is intended to
estimate the effects of short-term preoperative therapy with EGFR and Src inhibitors upon a
panel of biomarkers. The 4 treatment arms are erlotinib, dasatinib, their combination, and a
placebo. We anticipate accruing 56 evaluable patients (14 patients per arm).
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 |