Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others
interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Giving more than
one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses
high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab
together with combination chemotherapy and radiation therapy, with or without cisplatin, may
kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin
and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating
patients with metastatic head and neck cancer.
OBJECTIVES:
Primary
- Determine the increase in clinical/radiographic complete response rate in patients with
previously untreated metastatic squamous cell carcinoma of the head and neck treated
with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
- Determine the toxic effects of this regimen in these patients.
Secondary
- Determine the pattern of tumor recurrence in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the duration of response, time to progression, and survival of patients
treated with this regimen.
- Correlate effects of this regimen with biomarkers of response and predictors of
long-term outcome in these patients.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV
over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6
courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks
later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease
undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable
nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent
cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical
resection before or instead of radiotherapy or chemoradiotherapy.
Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of
radiotherapy or surgery.
After study completion, patients are followed every 3 months for 2 years, every 4 months for
1 year, and every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 |