Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	15 to 70	Other	EORTC-24981 NCT00025298

Objectives

1. 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.
2. Compare the feasibility and activity of these regimens in these patients.
3. Determine the toxicity of paclitaxel and carboplatin in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 15 to 70

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm³
• Platelet count at least 150,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Lisa Licitra, MD, Protocol chair		Ph: 39-2-239-0805 Email: lisa.licitra@istitutotumori.mi.it

Registry Information
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)
Trial Start Date		2001-07-11
Registered in ClinicalTrials.gov		NCT00025298
Date Submitted to PDQ		2001-08-08
Information Last Verified		2001-12-14

Back to Top