Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833261
• Other study ID #: CDR0000632295
• Secondary ID: SCCC-04308CA 225
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: May 2016

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: 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. Drugs used in chemotherapy, such as cisplatin, 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 cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Description:

OBJECTIVES:

Primary

• To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

• To determine the progression-free survival and local-regional progression in these patients.

• To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.

• To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract

• Recurrent disease or second primary SCC

• Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)

• Majority (= 75%) of the recurrent tumor must be in areas previously irradiated to = 45 Gy

• More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy

• Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)

• No signs of carotid exposure

• No primary nasopharyngeal or salivary gland tumor

• Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan

• No distant metastasis

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• ANC = 2,000/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 8.0 g/dL (transfusion or other intervention allowed)

• Bilirubin < 1.5 mg/dL

• AST or ALT < 2 times upper limit of normal

• Creatinine clearance = 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded

• No active cardiac disease, including 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

• At least 3 heart-related hospitalizations within the past year

• No severe chronic obstructive pulmonary disease requiring = 3 hospitalizations within the past year

• No concurrent medical illness that would impair patient tolerance to therapy or limit survival

• No other invasive malignancy within the past 2 years

• No pre-existing peripheral sensory neuropathy = grade 2

• No prior severe infusion reaction to a monoclonal antibody

• No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior surgery

• Prior cisplatin and cetuximab allowed

• At least 6 months since prior radiotherapy or chemotherapy

• No prior radiotherapy > 75 Gy

• No prior chemotherapy for recurrent head and neck cancer

• Prior chemotherapy as a component of the primary treatment allowed

• No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer

• Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cetuximab
cetuximab
• cisplatin
cisplatin

Radiation:
• intensity-modulated radiation therapy
IMRT

Drug:
• Nab-Paclitaxel
Nab-Paclitaxel

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.	2 year from the date of enrollment
Secondary	Number of Participants With Acute and Late Toxicities	Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.	6 months within the end of treatment