Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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) |
| Enrollment: | 5 |
| Study Start Date: | July 2001 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
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 |
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| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Italy | |
| Ospedale Santa Croce | |
| Cuneo, Italy, 12100 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milano (Milan), Italy, 20133 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Spain | |
| Hospital General de Jerez | |
| Jerez, Spain, 11407 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Turkey | |
| Istanbul University-Institute of Oncology | |
| Istanbul, Turkey, 34390 | |
| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Lisa Licitra, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00025298 History of Changes |
| Other Study ID Numbers: | EORTC-24981, EORTC-24981 |
| Study First Received: | October 11, 2001 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
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:
|
Head and Neck Neoplasms Nasopharyngeal Neoplasms Radiation Injuries Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Wounds and Injuries Cisplatin Carboplatin |
Paclitaxel Amifostine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Radiation-Protective Agents Protective Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013