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

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Nab-Paclitaxel

Drug: cetuximab

Drug: cisplatin

Radiation: intensity-modulated radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00833261

112008-004

SCCC-04308

CA 225314

CDR0000632295

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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