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

NCT ID: NCT00025298

Last Updated: 2012-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31

Brief Summary

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.

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.

Conditions

Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Oral Complications; Radiation Toxicity

Keywords

stage II nasopharyngeal cancer; stage III nasopharyngeal cancer; stage IV nasopharyngeal cancer; oral complications; drug/agent toxicity by tissue/organ; radiation toxicity

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

amifostine trihydrate

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Licitra, MD

Role: STUDY_CHAIR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

Institut Jules Bordet

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Centre Antoine Lacassagne

Nice, , France

Ospedale Santa Croce

Cuneo, , Italy

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, , Italy

Hospital General de Jerez

Jerez de la Frontera, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Istanbul University-Institute of Oncology

Istanbul, , Turkey (Türkiye)

Beatson Oncology Centre

Glasgow, Scotland, United Kingdom

Countries

Belgium; France; Italy; Spain; Turkey (Türkiye); United Kingdom

Other Identifiers

EORTC-24981

Identifier Type: -

Identifier Source: secondary_id

EORTC-24981

Identifier Type: -

Identifier Source: org_study_id