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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004094
First received: December 10, 1999
Last updated: January 3, 2014
Last verified: December 2002
  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 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.


Condition Intervention Phase
Head and Neck Cancer
Drug: carboplatin
Drug: fluorouracil
Drug: hydroxyurea
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1999
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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004094

Locations
United States, Illinois
Monroe Medical Associates
Chicago, Illinois, United States, 60603
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Study Chair: Athanassios Argiris, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00004094     History of Changes
Other Study ID Numbers: NU C98N1, NU-C98N1, UCCRC-9502, NCI-G99-1587
Study First Received: December 10, 1999
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Fluorouracil
Hydroxyurea
Paclitaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antisickling Agents
Enzyme Inhibitors
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014