NCT00833261 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-08-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Number of Participants With Acute and Late Toxicities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
intervention Names
Drug: cetuximab
Drug: cisplatin
Radiation: intensity-modulated radiation therapy
Drug: Nab-Paclitaxel
label
Single Arm: Chemotherapy with Concurrent Radiation therapy
type
EXPERIMENTAL

interventions

arm Group Labels
Single Arm: Chemotherapy with Concurrent Radiation therapy
description
cetuximab
name
cetuximab
other Names
chemo
type
DRUG
arm Group Labels
Single Arm: Chemotherapy with Concurrent Radiation therapy
description
cisplatin
name
cisplatin
other Names
chemo
type
DRUG
arm Group Labels
Single Arm: Chemotherapy with Concurrent Radiation therapy
description
IMRT
name
intensity-modulated radiation therapy
other Names
IMRT
type
RADIATION
arm Group Labels
Single Arm: Chemotherapy with Concurrent Radiation therapy
description
Nab-Paclitaxel
name
Nab-Paclitaxel
other Names
chemo
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 37
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Progression Free Survival (PFS)
time Frame
2 year from the date of enrollment

secondary Outcomes

description
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.
measure
Number of Participants With Acute and Late Toxicities
time Frame
6 months within the end of treatment

Full study description

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.

Source references

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.
pmid
29346519
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice