Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer

June 14, 2023 updated by: Eastern Cooperative Oncology Group

A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx

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 II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy.
  • Determine the feasibility and toxicity of this regimen in these patients.
  • Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen.
  • Determine the disease-free survival and patterns of failure of patients treated with this regimen.
  • Determine the objective tumor response rate (complete and partial response) in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin.
  • Determine changes in quality of life of patients treated with this regimen.
  • Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease site (larynx vs oropharynx).

Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of induction therapy, patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly, for 7 weeks beginning on day 1.

Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease (N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection. Patients with N1-N2 disease with complete response may also undergo neck dissection. Patients with initial complete response who recur at the primary site undergo surgical salvage.

Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24 months after completion of all therapy.

Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.

PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.

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
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute - Jacksonville
      • Lakeland, Florida, United States, 33804-5000
        • Watson Clinic, LLC
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, United States, 60616
        • Mercy Hospital and Medical Center
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology/Oncology
      • Niles, Illinois, United States, 60714
        • Cancer Care and Hematology Specialists of Chicagoland - Niles
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Associates - Skokie
      • Skokie, Illinois, United States, 60076
        • Hematology/Oncology of the North Shore at Gross Point Medical Center
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Wichita, Kansas, United States, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Cancer Care Center at MetroHealth Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Cancer Center at Guthrie Clinic Sayre
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic - Indianhead Center

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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx

    • No recurrent disease
    • No evidence of distant metastasis

  • Resectable disease, defined as follows:

    • High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
    • No extension to root of tongue (for disease of the base of tongue)
    • No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall)
    • No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)
    • No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)
    • No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis)

    • For disease of the supraglottis, glottis, or subglottis:

      • No base of the tongue invasion greater than 2 cm
      • No tumor extension through cartilage to involve strap muscles of the neck
      • No tumor fixation to prevertebral fascia
      • No involvement of the carotid artery
      • No fixed nodal disease with involvement of the deep neck
      • Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx

  • Measurable disease

    • - Lesions accurately measured in at least one dimension as > 20 mm (2.0 cm) with conventional techniques or as > 10 mm (1.0 cm) with spiral CT scan
    • Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion
  • No other concurrent head and neck neoplasms

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Not specified

Renal

  • Creatinine less than 3.0 mg/dL
  • Calcium normal

Cardiovascular

  • No significant cardiac disease
  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No myocardial infarction within the past year
  • No serious cardiac arrhythmias requiring medication

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study completion
  • No significant detectable infection
  • No history of allergy to drugs containing Cremophor EL
  • No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin
  • No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy
  • No concurrent amifostine

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy above the clavicles

Surgery

  • No prior surgery to the primary tumor except biopsy or debulking

Other

  • No concurrent experimental mucosal protectants

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in quality of life
Organ preservation rate
Feasibility and toxicity
Utility of pre- and post-treatment organ function instruments
Disease-free survival and patterns of failure
Objective tumor response rate (complete and partial response)
Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome

Collaborators and Investigators

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

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Anthony J. Cmelak, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 6, 2001

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068468
  • U10CA021115 (U.S. NIH Grant/Contract)
  • ECOG-2399

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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