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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
amifostine trihydrate
carboplatin
cisplatin
paclitaxel
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, oral complications, drug/agent toxicity by tissue/organ, radiation toxicity

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • CRLCC Nantes - Atlantique
  • Centre Antoine Lacassagne
  • Ospedale Santa Croce
  • Istituto Nazionale per la Ricerca sul Cancro
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Hospital General de Jerez
  • Hospital Universitario 12 de Octubre
  • Istanbul University-Institute of Oncology
  • Beatson Oncology Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00025298
Brief Title
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
July 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Licitra, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Milano (Milan)
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Hospital General de Jerez
City
Jerez
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Istanbul University-Institute of Oncology
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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

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