Chemotherapy Plus Radiation Therapy in Treating Patients With Squamous Cell Cancer of the Head and Neck

January 17, 2017 updated by: Robert I. Haddad, MD, Dana-Farber Cancer Institute

Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)

The purpose of this research study is to develop a new chemo radiotherapy regimen for the treatment of cancer of the head and neck for patients who have received induction chemotherapy; and to determine the highest dose of Taxotere which can be safely given together with radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this investigational research study investigators are attempting to develop a new chemo radiotherapy regimen in which radiotherapy and Taxotere will be combined after having received induction chemotherapy. Taxotere has never been given together with radiotherapy, the highest dose of Taxotere that can be safely used in this setting in unknown. Taxotere will be added to radiotherapy gradually as each subsequent group of 3-5 patients gets a larger dose. Taxotere doses will be increased until certain toxicities occur. This will help investigators determine the best way to combine Taxotere with radiotherapy and to use that knowledge to treat other patients with tumors like yours.

Study Type

Interventional

Enrollment (Actual)

22

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, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States
        • Harvard Community Health Plan

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

DISEASE CHARACTERISTICS:

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

  • Stage: Patients can 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. This excludes patients with exophytic T3N0 tumors or T1N1 lesions at the onset of induction therapy. Evaluable disease during induction therapy is required.

    --Required Prior therapy: Patients entered on this protocol must have received therapy with one of the following induction regimens, except as modified for toxicity:

    • PF: Cisplatin ≥ 80 mg/M2?course and FUra ≥ 1000 mg/M2/day for ≥ 4 days every ≤ 4 week
    • CF: Carboplatinum ≥ 300 mg/M2/course and FUra ≥1000mg/M2/day for ≥4 days for ≤ 4 week
    • PFL5: Cisplatin ≥ 25 mg/M2/day over 5 days, FUra ≥ 800mg/M2/day days 2-5 (4 days) and Leucovorin ≥ 500 mg/M2/day over 5 days, every 4 weeks.
    • TPF: Taxotere, Cisplatin ≥ 100 mg/M2/day over 5 days, FUra ≥ 700 mg/M2?day days 2-5 (4 days)
    • Patients treated as above are eligible provided that they receive no more than three cycles or, if not responding after 2 cycles; or 1 cycle with progressive disease p. 35 of archive doc

  • 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.
    • Patient with any non-SCCHN malignancy within 5 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 described in section 3.21 within the last 5 years are not eligible. 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 balances enteral intake (1,800 kcal/day). Patients requiring intravenous alimentation as primary source of calories are excluded from this study. Patients who experiences a weight loss of more than 20% of their body weight in the three months preceding presentation are ineligible. Patients with persistent diarrhea are ineligible.
    • 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 < 2.5x ULN for entry. Total Bilirubin and SGOT must be ≤ 2 x ULN as an isolated value. Alkaline phosphatase must be ≤ 2.5 x ULN as an isolated value.
    • Hematologic: WBC 4,000/mm3 or a normal absolute neutrophil count (ANC); Platelet count 100,000/mm3, Hemoglobin 10 gm/dl (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 eligibility criteria)
    • Neurologic: Peripheral neuropathy of any etiology must not exceed grade 1.
    • Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina
    • Other: Lack of other serious illness or medical condition
  • Allergies: Patients with prior allergy to polysorbate 80 (see appendix) are ineligible
  • Informed Consent: Patients must give written informed consent
  • Follow-up: All patients must be available for monthly evaluation and restaging by the head and neck cancer clinic on therapy

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

After the screening procedures confirm participation in the research study:

  • Taxotere-Administered weekly for 1 hour (6 doses)
  • Radiation Therapy (XRT) -5 days a week for 6 weeks
  • Exam under anesthesia
  • Neck Dissection (if indicated)
Radiation: Radiation therapy
Drug: Taxotere
Other Names:
  • Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD of weekly Taxotere
Time Frame: 6 Weeks
6 Weeks
Number of Participants of with Severe Adverse Events
Time Frame: 6 Weeks
6 Weeks

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: Marshall R. Posner, MD, 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

October 1, 1995

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 12, 2004

First Posted (Estimate)

August 13, 2004

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95-041
  • P30CA006516 (U.S. NIH Grant/Contract)
  • NCI-G98-1382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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