NCT00003206

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 1999

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Head and Neck Cancer

Keywords

stage IV nasopharyngeal cancerrecurrent nasopharyngeal cancer

Interventions

carboplatinDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (18)

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, 60611, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Pretoria Academic Hospital

Pretoria, 0001, South Africa

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNasopharyngeal Neoplasms

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Barbara A. Murphy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

October 6, 1999

Primary Completion

July 1, 2001

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

ZA(1)US(17)