Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003582
First received: November 1, 1999
Last updated: July 25, 2014
Last verified: August 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy and chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV head and neck cancer that cannot be surgically removed.


Condition Intervention Phase
Carcinoma of Unknown Primary
Head and Neck Cancer
Drug: amifostine trihydrate
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II Study to Evaluate Combined Hyperfractionated Radiation Therapy and 5-Fluorouracil, Cisplatin and Paclitaxel (Taxol) and Amifostine (WR 2721, Ethyol) in Stage III and IV Inoperable Head and Neck Carcinomas

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Estimated Enrollment: 36
Study Start Date: May 1988
Study Completion Date: December 1996
Primary Completion Date: December 1996 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Assess the impact of amifostine on the acute tolerance of combined hyperfractionated radiation therapy and fluorouracil, cisplatin, and paclitaxel with amifostine, in terms of the grade and duration of acute mucositis and dermatitis, and acute hematologic tolerance in patients with stage III or IV unresectable head and neck carcinoma. II. Determine the local control and survival associated with this regimen in these patients. III. Determine the long term chronic toxic effects of this regimen in terms of swallowing dysfunction, PEG dependency, and xerostomia in these patients. IV. Determine the quality of life post therapy by assessment of speech and swallowing function in these patients. V. Determine if radiation dose escalation in patients with treatment interruption achieve an isoeffect on locoregional control. VI. Determine the safe optimal dose of paclitaxel to be combined with hyperfractionated radiation therapy, fluorouracil, cisplatin, and amifostine in these patients. VII. Determine the correlation of p53 chromosome expression on locoregional control and survival of these patients. VIII. Quantitate tumor volumetrics and correlate with stage, resectability status, and locoregional control and survival of these patients.

OUTLINE: This is a dose escalation of paclitaxel, multicenter study. Patients are stratified by performance status, stage, institution, tumor volumetrics, resectability, and p53 expression. Patients receive amifostine IV over 10 minutes on Monday of weeks 1, 5, and 9, and over 5-7 minutes Tuesday through Friday of weeks 1, 5, and 9 and Monday through Friday of weeks 2, 3, 4, 6, and 7. Within 10-15 minutes of amifostine administration, patients receive paclitaxel IV over 3 hours, cisplatin IV over 2 hours on days 1, 29, and 56, and fluorouracil IV over 72 hours on days 1-4, 29-33, and 56-60. Starting on day 2, patients receive hyperfractionated external beam radiotherapy twice daily over 6.5 weeks, following amifostine IV over 5-7 minutes Monday through Friday. Cohorts of 6-20 patients each receive escalating doses of paclitaxel. Quality of life is assessed. Patients are followed monthly for 1 year, every 2 months for 1 year, every 6 months for 3 years, and then annually thereafter until death.

PROJECTED ACCRUAL: A minimum of 36 patients will be accrued for this study within 20 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck, including: Stage III or IV: oral cavity, paranasal sinus, hypopharynx, oropharynx, larynx, and nasopharynx OR Unknown primary carcinoma of the head and neck with greater than N1 disease if no planned neck dissection Evaluable disease No metastases below clavicle by clinical or radiographic diagnosis All hypopharynx and nasopharynx patients with N3 disease undergo a CT scan of the chest

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 130,000/mm3 WBC at least 3,400/mm3 Hemoglobin greater than 10.0 g/dL (transfusion allowed) Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No active heart disease No myocardial infarction within past 6 months No uncontrolled congestive heart failure No uncontrolled angina Cardiac ejection fraction at least 50% by MUGA scan for patients under 65 without antecedent heart disease, at least 55% for patients over 65 and/or with antecedent heart disease Pulmonary: FEV greater than 60% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the treatment field Surgery: Eligible for PEG gastrostomy Other: At least 24 hours since prior antihypertensive and diuretic medications (prior to amifostine and chemotherapy regimens)

  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: NCT00003582

Locations
United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Andre A. Abitbol, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003582     History of Changes
Other Study ID Numbers: UMIAMI-88191, SCCC-1988007, ALZA-97-052-ii, BHM-98-32, NCI-V98-1474
Study First Received: November 1, 1999
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
squamous cell carcinoma of unknown primary
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Amifostine
Cisplatin
Fluorouracil
Paclitaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014