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

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00025298

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Amifostine Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2001

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025298

Locations

Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
France
Centre Antoine Lacassagne
Nice, France, 06189
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Ospedale Santa Croce
Cuneo, Italy, 12100
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital General de Jerez
Jerez, Spain, 11407
Turkey
Istanbul University-Institute of Oncology
Istanbul, Turkey, 34390
United Kingdom, Scotland
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Lisa Licitra, MD

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068947, EORTC-24981
Study First Received:	October 11, 2001
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00025298 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Radiation-Protective Agents
Otorhinolaryngologic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Cisplatin
Therapeutic Uses
Nasopharyngeal Diseases
Otorhinolaryngologic Diseases
Amifostine

Mitosis Modulators
Carboplatin
Antimitotic Agents
Pharyngeal Diseases
Protective Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Head and Neck Neoplasms
Tubulin Modulators
Stomatognathic Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 08, 2010