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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006107   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes

August 3, 2000
February 6, 2009
March 2000
 
 
 
Complete list of historical versions of study NCT00006107 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: 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.

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.

Phase I
Interventional
Treatment
Head and Neck Cancer
  • Drug: docetaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma)

    • Stage III or IV (M0) disease
  • Must have had prior platinum/fluorouracil based initial induction chemotherapy (may have included a taxane)

    • Previously untreated disease prior to induction regimen
    • Received 1-3 courses of chemotherapy and less than 7 weeks from the beginning of the last course of induction therapy
    • Evaluable disease during induction therapy required
  • No prior head and neck carcinoma except if treated with surgery as sole modality at least 2 years prior to study

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3 OR
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

  • SGOT less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN
  • Bilirubin normal
  • SGOT no greater than 2 times ULN

Renal:

  • Not specified

Cardiovascular:

  • No acute cardiac dysrhythmias or unstable cardiac condition (e.g., angina)

Other:

  • No other concurrent malignancy within the past 3 years except curatively treated limited basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day)
  • No persistent diarrhea
  • No peripheral neuropathy of any etiology greater than grade 2
  • No other serious illness or medical condition
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 5 years since any other form of prior chemotherapy

Endocrine therapy:

  • Prior hormonal therapy allowed

Radiotherapy:

  • No prior radiotherapy for SCCHN

Surgery:

  • See Disease Characteristics
  • Percutaneous endoscopic gastrostomy required prior to radiotherapy

Other:

  • No IV alimentation as primary source of calories
  • Completely recovered from prior diagnostic or therapeutic procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006107
 
CDR0000068118, DFCI-99274, NCI-G00-1833
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Roy B. Tishler, MD, PhD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP