Trial record 21 of 2115 for:    Oral Cancer | NIH

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004094
Recruitment Status : Unknown
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2003
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

December 10, 1999
May 8, 2003
January 6, 2014
August 1999
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Complete list of historical versions of study NCT00004094 on Archive Site
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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth, Pharynx, or Larynx
A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer

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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth, pharynx, or larynx.


  • Evaluate the activity of induction chemotherapy with carboplatin and paclitaxel followed by concurrent fluorouracil, hydroxyurea, paclitaxel, and hyperfractionated radiotherapy in terms of response rate, pattern of failure, time to progression, and overall survival in patients with previously untreated advanced oral, pharyngeal, or laryngeal cancer.
  • Assess this treatment regimen in terms of the pattern and degree of clinical acute, cumulative, and chronic toxic effects in this patient population.
  • Assess the rate of organ preservation in resectable patients treated with this regimen.
  • Evaluate the quality of life, organ function, and incidence of second primary tumors in patients treated with this regimen.
  • Assess the rate of complications with subcutaneously implanted IV infusion catheters in patients treated with this regimen.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes weekly for 3 weeks. Treatment repeats every 4 weeks for 2 courses.

At 1-2 weeks after completion of induction chemotherapy, patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, radiotherapy twice daily on days 1-5, and paclitaxel IV over 1 hour on day 2. Treatment repeats every 2 weeks for 5 courses.

Patients with residual nodal disease or initially staged nodal disease in the absence of macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy. Patients with residual disease at the primary site undergo complete excision of disease. Patients with disease progression or disease recurrence are considered for conventional surgical management.

Quality of life is assessed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 12-18 months.

Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: carboplatin
  • Drug: fluorouracil
  • Drug: hydroxyurea
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Histologically or cytologically confirmed squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the head and neck

    • Stage III carcinoma of the base of the tongue or hypopharynx
    • Stage IV carcinoma of the oral cavity, pharynx (including nasopharynx, oropharynx, and hypopharynx), or larynx
  • No distant metastasis
  • Measurable disease desirable

    • Clinically disease free after prior surgery allowed



  • 15 to 80

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


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


  • Creatinine no greater than 2.0 mg/dL


  • No clinically significant cardiomyopathy or congestive heart failure


  • No clinically significant pulmonary dysfunction


  • No severe baseline neurologic deficits
  • No uncontrolled active infection other than that not curable without treatment of cancer
  • No sensitivity to Cremophor EL
  • Not pregnant or nursing


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics
  • Incisional or excisional biopsy and organ sparing procedures (e.g., debulking of airway compromising tumors or neck dissection) in patients with an existing primary tumor allowed
  • No more than 3 months since prior nonbiopsy procedure
Sexes Eligible for Study: All
15 Years to 80 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NU C98N1
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University of Chicago
National Cancer Institute (NCI)
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Study Chair: Athanassios Argiris, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
December 2002

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