Head and Neck Cancer Clinical Trial
Official title:
A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
Verified date | July 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
formulation and cisplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to
grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances
to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel
albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation
therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation
together with cisplatin and cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel
albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab,
and radiation therapy to see how well they work in treating patients with locally advanced
stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 37 |
Est. completion date | August 3, 2015 |
Est. primary completion date | October 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx - Diagnosis based on the primary lesion and/or lymph nodes - Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0) - No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands - No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - ANC > 1,500/mm^3 - Platelet count > 100,000/mm^3 - Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed) - Bilirubin = 1.5 mg/dL - AST, ALT, and AP = 2.5 times upper limit of normal - Serum creatinine = 1.5 mg/dL - Creatinine clearance = 50 mL/min - None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0: - Calcium < 7 mg/dL or > 12.5 mg/dL - Glucose < 40 mg/dL or > 250 mg/dL - Magnesium < 0.9 mg/dL or > 3 mg/dL - Potassium < 3 mmol/L or > 6 mmol/L - Sodium < 130 mmol/L or > 155 mmol/L - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for = 3 years - No prior allergic reaction to study drugs - No active cardiac disease, defined as any of the following: - Unstable angina - Uncontrolled hypertension - Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) - Uncontrolled arrhythmia - Congestive heart failure - Three or more heart-related hospitalizations within the past year - No severe chronic obstructive pulmonary disease requiring = 3 hospitalizations within the past year - No AIDS - No pre-existing peripheral sensory neuropathy = grade 2 - No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival PRIOR CONCURRENT THERAPY: - No prior systemic chemotherapy for this cancer - Prior systemic chemotherapy for a different cancer allowed - No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields - No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease) - At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy - No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin) |
Country | Name | City | State |
---|---|---|---|
United States | Baylor Research Institute | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase I Maximum Tolerated Dose of Nab-Paclitaxel | Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m^2. | 90 days | |
Primary | Phase II 2-year Progression-free Survival | Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death. |
2 year | |
Secondary | Phase II 2-year Local Control | Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions | 2 year | |
Secondary | Phase II 2-year Overall Survival | median follow-up 24 months for 34 patients | 2 year |
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 |