Clinical trial NCT02057107: SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN
Official title: Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Previously-Irradiated
Squamous Cell Carcinoma of the Head and Neck Cancer
Keywords: Stereotactic Body Radiation Therapy (SBRT)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine before assigning treatment to either cetuximab and SBRT only or cetuximab, SBRT, and docetaxel.

Detailed description: The aim of this trial is to examine the addition of docetaxel on the overall survival of patients otherwise treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).

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 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 (ECOG 0-1)
* Prior treatment with an 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 (MRI, CT, PET-CT or physical exam)
* Age \> 18
* Estimated life expectancy \> 12 weeks
* No prior radiation therapy or chemotherapy within 1 month of study enrollment
* ANC \> 1000, 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

Primary outcomes:
measure: 1-Year Locoregional Progression-free survival (PFS)
timeFrame: Up to 12 months
measure: Incidence of distant disease
timeFrame: Up to 12 months
measure: Acute toxicities
timeFrame: Up to 3 months after SBRT treatment
measure: Late toxicities
timeFrame: From 3 months after SBRT treatment, up to 3 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 12 months
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: University of Washington QOL Assessment Tool (UW-QOL)
timeFrame: Up to 5 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: David A Clump, MD
role: PRINCIPAL_INVESTIGATOR
References: