Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

June 15, 2017 updated by: Roy B. Tishler, MD, Dana-Farber Cancer Institute

Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)

Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
  • Determine the toxicity of this treatment regimen in this patient population.
  • Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.

Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.

Patients are followed monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathology:

    -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.).

  • Stage:

    -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required.

    • Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan.
    • Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy.

  • Other Malignancies:

    • Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry.
    • Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
    • Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.

  • Other Prior Therapy:

    • Patients treated with induction therapy
    • Hormonally treated patients are eligible.

  • Performance: Patients must meet the following performance criteria:

    • Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required.
    • Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day).
    • A PEG is required prior to initiation of radiation.
    • Age: ≥18 years
    • Life Expectancy: Longer than 3 months.
    • Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy.

  • Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows:

    • Hepatic: SGOT < 1.5 x ULN and Alkaline Phosphatase < 2.5 x ULN for entry. Total Bilirubin = WNL and SGOT must be ≤ 2 x ULN as an isolated value. SGPT ≤ 2.5 x ULN
    • Hematologic: WBC ≥ 3,000/mm3 or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria).
  • Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.
  • Other: Lack of other serious illness or medical condition

  • Informed consent:

    -- Patients must give written informed consent.

  • Follow-up:

    • All patients must be available for monthly evaluation and re-staging by the physicians from the Head and Neck Cancer Clinic while on therapy.

Exclusion Criteria:

  • Pathology:

    -- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry.

  • Other Malignancies:

    • Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
    • Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.

  • Other Prior Therapy:

    • Patients who were previously treated with radiotherapy for SCCHN are not eligible.
    • Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible

  • Performance:

    • Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study.
    • Patients with persistent diarrhea are ineligible.

  • Organ Function:

    -- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.

    -- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina.

  • Follow-up:

    • Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taxotere
  • Taxotere: (1 hour infusion once a week for four weeks)
  • Radiation Therapy (5 days/week for 6-7 weeks)
  • Surgery (if required) 14 -12 weeks after radiotherapy
  • Follow-up
Radiation: radiation therapy
Procedure: Surgery
Drug: Taxotere
Other Names:
  • Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD of Taxotere
Time Frame: 8 Weeks
8 Weeks
Dose Limiting Toxicity
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 4-12 weeks post chemo/radiation therapy
4-12 weeks post chemo/radiation therapy
Tumor Resistance Predictors
Time Frame: Up to 1 year post chemo/radiation therapy
Tumor Biopsies and tissues
Up to 1 year post chemo/radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roy B. Tishler, MD, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2000

Primary Completion (Actual)

July 17, 2003

Study Completion (Actual)

July 3, 2004

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-274
  • P30CA006516 (U.S. NIH Grant/Contract)
  • NCI-G00-1833

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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