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


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Head Lice

Lice; Lice Infestation 




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

This study is no longer recruiting patients.

Sponsors and Collaborators: Dana-Farber/Harvard Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
Head and Neck Cancer
 Drug: docetaxel
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: radiation therapy
 Procedure: radiosensitization
 Procedure: surgery
Phase I

MedlinePlus related topics:  Head and Neck Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Docetaxel With Concurrent Boost Radiotherapy in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Previously Treated With Induction Chemotherapy

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 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:

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:

Radiotherapy:

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

Location Information


Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Roy B. Tishler, MD, PhD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068118; DFCI-99274; NCI-G00-1833
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006107
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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December 1, 2009



Page Updated: October 15, 2009
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