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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003200
First received: November 1, 1999
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer
Drug: Taxotere
Radiation: Radiation therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • MTD of weekly Taxotere [ Time Frame: 6 Weeks ]
  • Number of Participants of with Severe Adverse Events [ Time Frame: 6 Weeks ]

Enrollment: 22
Study Start Date: October 1995
Study Completion Date: June 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Taxotere
Other Name: Docetaxel
Radiation: Radiation therapy

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003200

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Harvard Community Health Plan
Boston, Massachusetts, United States
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marshall R. Posner, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Robert I. Haddad, MD, Haddad, Robert MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00003200     History of Changes
Other Study ID Numbers: 95-041
P30CA006516 ( US NIH Grant/Contract Award Number )
NCI-G98-1382
Study First Received: November 1, 1999
Last Updated: January 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 22, 2017