Head and Neck Cancer Clinical Trial
Official title:
Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Verified date | April 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when
given together with carboplatin followed by radiation therapy in treating patients with
stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 48 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following types: - Oral cavity - Oropharynx - Hypopharynx - Clinical stage III-IVB (T2-T4, N0-N3, M0) disease - Measurable disease by physical exam, endoscopy, and/or CT scan or MRI - Residual measurable disease after fine needle aspiration, core needle biopsy, or incisional or excisional biopsy of the primary tumor - No evidence of distant metastases (M1) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 - Hemoglobin > 9 g/dL - No uncontrolled coagulopathy Hepatic - AST < 2 times normal - Alkaline phosphatase < 2 times normal - Bilirubin normal Renal - Creatinine < 2.0 mg/dL OR - Creatinine clearance > 50 mL/min Cardiovascular - No congestive heart failure - No symptomatic coronary artery disease - No uncontrolled cardiac arrhythmias - No myocardial infarction within the past year - No other clinically significant cardiac disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment - Nutritional and general physical condition must be compatible with proposed study treatment - Mentally reliable - No pre-existing peripheral neuropathy > grade 1 - No history of hypersensitivity to fluorouracil, capecitabine, or carboplatin - No active infection - No other malignancy within the past 5 years except nonmelanoma skin cancer - No major medical, psychiatric, or neurologic illness that would preclude study participation or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 5 years since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for head and neck tumor - No prior radiotherapy to the region of planned study radiotherapy fields Surgery - Recovered from prior surgery - No unhealed surgical wounds Other - More than 4 weeks since prior investigational drugs - No concurrent warfarin, diphenylhydantoin, or fluconazole unless willing to undergo careful monitoring and appropriate dose adjustments |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Cancer Center at UV Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | National Cancer Institute (NCI) |
United States,
Thomas CY, Read P, Petroni G, Reibel J, Levine PA. Phase I study of capecitabine, carboplatin and intensity-modulated radiation therapy for head and neck cancer. Anticancer Res. 2009 Jul;29(7):2869-73. — View Citation
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 |