Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

NCT02110992 | Terminated Phase 1 DMC

• 1 other identifier: UCCI-HN-13-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Number of acute dose limiting toxicities

  Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture

  3 months

Secondary Outcomes (4)

• Locoregional control

  2 years

• Disease-free survival

  2 years

• overall survival

  2 years

• Number of late effect dose limiting toxicities

  2 years

Study Arms (1)

Docetaxel + Stereotactic Radiation

EXPERIMENTAL

Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by \> 48 hours.

Drug: Docetaxel; Radiation: Stereotactic Radiation

Interventions

Docetaxel DRUG

Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT

Also known as: Taxotere, NDC 0075-8001-20

Docetaxel + Stereotactic Radiation

Stereotactic Radiation RADIATION

SBRT will be given over 5 fractions separated by \> 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.

Also known as: SBRT, Stereotactic Body Radiation, Radiation Therapy

Docetaxel + Stereotactic Radiation

Eligibility Criteria

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

You may qualify if:

• Recurrent or second primary squamous cell head and neck cancer
• Defined area of recurrence on imaging
• Previous head and neck radiation (RT) to \>/= 50 Gy
• Performance status score 0-1
• Time interval from previous RT \>/= 9 months
• Volume of disease appropriate for protocol treatment
• Minimum estimated survival of \>/= 3 months
• Age \>/= 18
• Adequate labs

You may not qualify if:

• Primary tumors of the salivary gland
• Original pathology report and radiation therapy records not available
• Prior spinal cord dose \> 45 Gy
• Surgery or chemotherapy within 4 weeks
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267-0502, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Radiosurgery; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brad Huth, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2014
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)