Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Oncology/Hematology West
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00713219
First received: July 9, 2008
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Another approach that has been used in clinical trials is to treat patients with a repeat course of radiation. In these studies, some patients received chemotherapy at the same time as the radiation.

In this clinical study, we wish to treat with radiation plus two drugs during the course of reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer cells.

The radiation will be administered using a strategy called intensity-modulated radiation therapy (IMRT), which focuses the radiation beam on the tumor.

Docetaxel and cetuximab are both approved for the treatment of patients with head and neck cancer.

However, the combination of radiation + docetaxel + cetuximab for patients with recurrent head and neck cancer is considered to be a topic for clinical research. The purpose of this study is to determine the good and bad effects of treatment with radiation + docetaxel + cetuximab.


Condition Intervention Phase
Head and Neck Cancer
Radiation: IMRT, cetuximab, docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity -Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The primary endpoint is 2-year progression-free survival (PFS). [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of re-irradiation + docetaxel + cetuximab for patients with locoregionally recurrent head and neck cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
  • To estimate median overall survival for this patient population. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
  • To estimate 2-year locoregional control for this patient population. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: July 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CHEMORADIATION
Radiation: IMRT, cetuximab, docetaxel
IMRT will be administered in once daily fractions (2 Gy/day, Monday through Friday) over approximately 7 weeks to a goal of approximately 70 Gy. The chemotherapy regimen will begin with a loading dose of intravenous cetuximab (400 mg/m2) one week prior to the initiation of radiation therapy, followed by weekly administration of intravenous docetaxel (15 mg/m2) and intravenous cetuximab (250 mg/m2) for approximately 7 weeks concurrently with radiation. Patients will be evaluated weekly prior to their chemotherapy. All patients will be evaluated on an intention-to-treat basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in patients with past history of definitive radiation therapy for head and neck cancer. Patients in whom the initial diagnosis was neck metastasis with suspected occult primary in the head and neck will be eligible.

Patients with histologic variants such as spindle cell carcinoma, poorly-differentiated keratin postive carcinoma, and lymphoepithelioma will be eligible.

  • Patients may be eligible if they have unresected recurrent disease in the prior radiation field. Patients also may be eligible if they have undergone surgical resection of recurrent disease in the prior radiation field with any of the following poor risk pathologic features:

    • Malignant involvement of 2 or more regional lymph nodes
    • Extracapsular extension of nodal disease
    • Microscopically involved mucosal margins of resection (at 5 mM or less)
    • Perineural involvement
    • Resected soft tissue disease
    • Oral cavity or oropharyngeal primaries with nodal disease at levels IV or V
  • Patients must have had prior radiation for head and neck cancer with ≥ 50 % of the recurrent tumor within areas that have been radiated to at least 45 Gy, but not exceeding 72 Gy.
  • Greater than 6 month interval from prior external beam radiation treatment. (Patients who have received intra-operative radiation therapy [IORT] within 6 months of registration may be eligible, if there has been no subsequent disease recurrence in the IORT field and criteria for eligibility are otherwise met).
  • KPS > or = to 70%
  • Age > or = to 18years
  • Adequate bone marrow function: ANC > or = to 1,500/μl, platelets > or = to 100,000/μl, Hgb > or = to 8 g/dL.
  • Adequate hepatic function.
  • Women of childbearing potential must have a negative pregnancy test.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least three months thereafter.
  • Patient must sign an informed consent document.

Exclusion Criteria:

  • Anticipated lifetime spinal cord dose exceeding 54 Gy, brain stem exceeding 65 Gy, optic chiasm exceeding 55 Gy, and optic nerves exceeding 60 Gy.
  • Three or more palliative cytotoxic chemotherapy regimens in the recurrent or metastatic disease setting.
  • Pregnancy or lactation.
  • Distant metastatic disease.
  • Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with nonmelanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
  • Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate-80.
  • History of severe infusion reaction to a monoclonal antibody.
  • Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713219

Locations
United States, Nebraska
Oncology/Hematology West
Omaha, Nebraska, United States, 68114
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07939
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Oncology/Hematology West
Investigators
Principal Investigator: Matthew Fury, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00713219     History of Changes
Other Study ID Numbers: 08-050
Study First Received: July 9, 2008
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
IMRT
cetuximab
docetaxel

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014