Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00025298
First received: October 11, 2001
Last updated: September 20, 2012
Last verified: September 2012
  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. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.


Condition Intervention Phase
Drug/Agent Toxicity by Tissue/Organ
Head and Neck Cancer
Oral Complications
Radiation Toxicity
Drug: amifostine trihydrate
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 5
Study Start Date: July 2001
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine.
  • Compare the feasibility and activity of these regimens in these patients.
  • Determine the toxicity of paclitaxel and carboplatin in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs stable disease vs not evaluable), and participating center.

Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization. Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV on days 1, 22, and 43. Patients also undergo radiotherapy daily 5 days a week for 6.5 weeks.
  • Arm II:Patients receive amifostine subcutaneously daily. Patients receive chemotherapy and radiotherapy as in arm I.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)

    • Locoregionally advanced disease

      • T2b, N1 (greater than 3 cm) or N2
      • T3, N1 (greater than 3 cm) or N2
      • T4, N1 (greater than 3 cm) or N2
      • Any T, N3
    • No squamous cell histology
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
  • No evidence of distant metastases
  • No signs or symptoms of CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 15 to 70

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 150,000/mm^3
  • Hemoglobin at least 12 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal:

  • Creatinine clearance at least 70 mL/min
  • Calcium normal

Cardiovascular:

  • No hypotension or hypertension requiring therapy
  • No prior myocardial infraction
  • No pre-existing uncontrolled cardiac disease
  • No signs of cardiac failure
  • No rhythm disturbances requiring medication

Other:

  • No sensory neuropathy grade 2 or greater unless due to cranial nerve
  • No uncontrolled infections
  • No sensitivity to aminothiol compounds
  • No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • No prior chemotherapy for UNPC

Endocrine therapy:

  • No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis

Radiotherapy:

  • No prior radiotherapy for UNPC

Surgery:

  • No prior surgery for UNPC except cervical lymphadenectomy

Other:

  • At least 1 month since prior investigational agent
  • No other concurrent anticancer drugs
  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: NCT00025298

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Italy
Ospedale Santa Croce
Cuneo, Italy, 12100
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Spain
Hospital General de Jerez
Jerez, Spain, 11407
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Turkey
Istanbul University-Institute of Oncology
Istanbul, Turkey, 34390
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Lisa Licitra, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00025298     History of Changes
Other Study ID Numbers: EORTC-24981, EORTC-24981
Study First Received: October 11, 2001
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage II nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
oral complications
drug/agent toxicity by tissue/organ
radiation toxicity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries
Cisplatin
Carboplatin
Paclitaxel
Amifostine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014