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

NCT00025298 | Terminated Phase 2

• 1 other identifier: EORTC-24981
• Study Type: interventional
• Target: 5
• Locations: 6 countries
• Sites: 13

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.

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

Interventions

amifostine trihydrate DRUG

carboplatin DRUG

cisplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (13)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Hospital General de Jerez

Jerez de la Frontera, 11407, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Istanbul University-Institute of Oncology

Istanbul, 34390, Turkey (Türkiye)

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Head and Neck Neoplasms; Radiation Injuries; Nasopharyngeal Neoplasms

Interventions

Amifostine; Carboplatin; Cisplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Wounds and Injuries; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Lisa Licitra, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: October 1, 2002
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

IT (4); ES (2); TU (1); FR (2); BE (3); GB (1)