SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN

NCT02057107 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: HCC 11-112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Previously-Irradiated; Squamous Cell Carcinoma of the Head and Neck Cancer

Keywords

Stereotactic Body Radiation Therapy (SBRT)

Outcome Measures

Primary Outcomes (4)

• 1-Year Locoregional Progression-free survival (PFS)

  The proportion of previously-irradiated patients treated with SBRT, cetuximab, and/or docetaxel, evaluated by PET/CT per RECIST Criteria v1.1 that do not experience locoregional disease progression within one year. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

  Up to 12 months

• Incidence of distant disease

  The proportion of patients with distant disease evaluated by PET/CT or CT per RECIST Criteria v1.1. Malignant disease that has spread to other organs or to lymph nodes other than those near the primary tumor. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

  Up to 12 months

• Acute toxicities

  Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria.

  Up to 3 months after SBRT treatment

• Late toxicities

  Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria.

  From 3 months after SBRT treatment, up to 3 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 12 months

• Overall Survival (OS)

  Up to 5 years

• University of Washington QOL Assessment Tool (UW-QOL)

  Up to 5 years

• Progression-free Survival (PFS)

  Up to 5 years

Study Arms (2)

SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel

OTHER

Previously Treated With Cetuximab - Group A; No Previous Cetuximab - Group C

Radiation: SBRT; Drug: Cetuximab; Drug: Docetaxel

SBRT + Cetuximab followed by Cetuximab

OTHER

Previously Treated with Cetuximab - Group B; No Previous Cetuximab - Group D

Radiation: SBRT; Drug: Cetuximab

Interventions

SBRT RADIATION

8.8-10 Gy per fraction (total: 44-50 Gy)

Also known as: Radiosurgery, Stereotactic radiosurgery, CyberKnife, True Beam, Trilogy

SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel; SBRT + Cetuximab followed by Cetuximab

Cetuximab DRUG

Day -7 (One week prior to commencement of stereotactic radiosurgery): Cetuximab, 400 mg/m2 Days 0 and 8 (The 1st and 2nd week of radiosurgery): Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)

Also known as: Erbitux

SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel; SBRT + Cetuximab followed by Cetuximab

Docetaxel DRUG

Days 0 and 8 (The 1st and 2nd week of radiosurgery) Docetaxel, 25 mg/m2 Docetaxel, 25 mg/m2 will be given weekly (following radiosurgery)

Also known as: Taxotere

SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heath Skinner: lead

Study Sites (1)

UPMC Hillman Cancer Center - Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiosurgery; Cetuximab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• David A Clump, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Dept. of Radiation Oncology and Associate Professor of Medicine

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 6, 2014
• Study Start: July 3, 2013
• Primary Completion: March 15, 2019
• Study Completion: December 31, 2019
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)