Carboplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer

NCT ID: NCT00003206

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Principal Investigators

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Barbara A. Murphy, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

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Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Site Status

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

Site Status

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

CCOP - Northern New Jersey

Hackensack, New Jersey, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt Cancer Center

Nashville, Tennessee, United States

Site Status

Pretoria Academic Hospital

Pretoria, , South Africa

Site Status

Countries

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United States South Africa

Other Identifiers

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E-2397

Identifier Type: -

Identifier Source: secondary_id

CDR0000066059

Identifier Type: -

Identifier Source: org_study_id

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