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

January 3, 2014 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 2

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Chicago, Illinois, United States, 60603
        • Monroe Medical Associates

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

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 15 to 80

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No clinically significant cardiomyopathy or congestive heart failure

Pulmonary:

  • No clinically significant pulmonary dysfunction

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Athanassios Argiris, MD, Robert H. Lurie Cancer Center

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

August 1, 1999

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

May 7, 2003

First Posted (Estimate)

May 8, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU C98N1
  • NU-C98N1
  • UCCRC-9502
  • NCI-G99-1587

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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