- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003206
Carboplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer
A Phase II Trial of Carboplatin Plus Paclitaxel in the Treatment of Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients with locally recurrent or metastatic nasopharyngeal cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Estimate the response and toxicity of carboplatin in combination with paclitaxel in patients with locally recurrent or metastatic nasopharyngeal carcinoma.
OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. This cycle is repeated every 3 weeks. Patients may receive 6-8 cycles of therapy in the absence of toxicity and disease progression. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.
PROJECTED ACCRUAL: 30 eligible patients will be accrued in approximately 18 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pretoria, South Africa, 0001
- Pretoria Academic Hospital
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California
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Palo Alto, California, United States, 94304
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611
- Veterans Affairs Medical Center - Chicago (Lakeside)
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Michigan
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New York
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or metastatic nasopharyngeal carcinoma that is not curable with resection or radiation therapy Bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 3.0 mg/dL Other: No active infections Serum calcium within institutional normal range No history of hypercalcemia Prior malignancy other than nasopharyngeal carcinoma allowed No concurrent malignancy Not pregnant or lactating Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No prior chemotherapy for metastatic or recurrent disease Prior induction or adjuvant chemotherapy concurrent with radiation therapy allowed No prior treatment with paclitaxel Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- CDR0000066059
- E-2397
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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