Stereotactic Radiosurgery and Cetuximab with or without Docetaxel in Treating Patients with Recurrent Head and Neck Cancer Previously Treated with Radiation Therapy

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActiveOver 1811-112
NCI-2014-01954, UPCI 11-112, REN13090047, NCT02057107

Trial Description

Summary

This randomized phase II trial studies how well stereotactic radiosurgery and cetuximab with docetaxel work compared with stereotactic radiosurgery and cetuximab alone in treating patients with head and neck cancer previously treated with radiation therapy that has come back after a period of improvement (recurrent). Stereotactic radiosurgery, also called stereotactic body radiation therapy (SBRT), is a type of external radiation therapy technique where the tumor is precisely localized and a very large amount of radiation is delivered to the tumor. Monoclonal antibodies, such as cetuximab, may block the growth of tumor cells by targeting a certain protein that regulates tumor growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving stereotactic radiosurgery and cetuximab with or without docetaxel is more effective in killing tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the 1-year locoregional progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with SBRT (stereotactic radiosurgery) and cetuximab and docetaxel.

II. To evaluate the acute and late toxicities associated with the above therapy.

TERTIARY OBJECTIVES:

I. To evaluate the impact of adjuvant docetaxel and cetuximab on incidence of distant disease.

II. To determine the objective response rate, PFS, and overall survival (OS) of the novel regimen.

III. To evaluate the impact of docetaxel on response rates with SBRT.

IV. To assess the toxicity of combination docetaxel-cetuximab and SBRT.

V. To evaluate changes in tumor glucose metabolism post-therapy as assessed by fludeoxyglucose F 18 (FDG)-positron emission tomography (PET).

VI. To evaluate the expression of tumor-specific biomarkers before and after treatment.

VI. To evaluate the impact of study interventions on patient-reported quality of life (PR-QOL).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cetuximab intravenously (IV) over 120 minutes on day -7 one week prior to stereotactic radiosurgery (SRS). Patients undergo SRS for a total of 5 fractions and receive concurrent cetuximab IV over 60 minutes and docetaxel IV over 60 minutes on days 0 and 8. Patients then receive cetuximab IV over 60 minutes and docetaxel IV over 60 minutes weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cetuximab IV over 120 minutes on day -7 one week prior to SRS. Patients then undergo SRS and receive concurrent cetuximab as in Arm I. Patients then receive cetuximab IV over 60 minutes weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6-8 weeks and then every 3 months for 16 months.

Eligibility Criteria

Inclusion Criteria:

Histologically-proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy; new primary is allowed if location is in a previously irradiated field; biopsy is recommended for each recurrence but is not mandated per study; this will be at the discretion of the principal investigator

Prior radiation dose of at least 50 gray (Gy)

Disease confined to locoregional site and can be encompassed in a stereotactic body radiosurgery “portal”

Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria; these criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk

Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients; a minimum of 4 weeks should elapse between any surgery and treatment on study; however, high-risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion

Karnofsky performance status >= 60 (Eastern Cooperative Oncology Group [ECOG] 0-1)

Prior treatment with an endothelial growth factor receptor (EGFR) inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy

Any number of prior chemotherapy regimens are allowed

Measurable disease on imaging studies (magnetic resonance imaging [MRI], computed tomography [CT], PET-CT or physical exam)

Estimated life expectancy > 12 weeks

No prior radiation therapy or chemotherapy within 1 month of study enrollment

Absolute neutrophil count (ANC) > 1000

Platelet (PLT) > 75,000

Serum creatinine < 2.5 mg/dL

Bilirubin < 1.5 x upper limits of normal (ULN)

Diabetes must be controlled prior to PET-CT scanning (blood glucose < 200 mg/dL)

Ability to provide written informed consent

Exclusion Criteria:

Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies

Patients in their reproductive age group should use an effective method of birth control; patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study

Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator

Concurrent serious infection

History of known hypersensitivity to cetuximab, docetaxel or similar agents

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

UPMC-Shadyside Hospital

  • National Cancer Institute
Dwight Earl Heron, Principal Investigator

Trial Sites

U.S.A.

Pennsylvania
Pittsburgh

UPMC-Presbyterian Hospital

Robert Louis Ferris
Ph: 412-647-2024
Email: ferrisrl@upmc.edu

Robert Louis Ferris
Principal Investigator

UPMC-Shadyside Hospital

Dwight Earl Heron
Ph: 412-623-6723
Email: heronD2@upmc.edu

Dwight Earl Heron
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02057107

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.