Clinical trial NCT00833261: Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: recurrent hypopharynx Cancer
recurrent larynx Cancer
recurrent verrucous carcinoma
squamous cell carcinoma
recurrent oral cavity cancer
recurrent metastatic occult primary cancer
recurrent oropharynx cacner
recurrent paranasal sinus and nasal cavity cancer
tongue cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 year from the date of enrollment
Secondary outcomes:
measure: Number of Participants With Acute and Late Toxicities
timeFrame: 6 months within the end of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Awan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.