Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

This study has been completed.

First Received: October 11, 2004 Last Updated: August 20, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00094081

Purpose

The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: tirapazamine (SR259075) Drug: cisplatin Procedure: Radiation Therapy	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Cisplatin Tirapazamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Overall survival.

Secondary Outcome Measures:

Time to locoregional failure.

Enrollment:	861
Study Start Date:	October 2002
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
Stage III or IV disease (excluding T1N1, and T2N1).
ECOG performance status less than or equal to 2.
Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL.
Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN.
Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.

Exclusion Criteria:

Metastatic Disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094081

Locations

United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
United States, Florida
H-Lee Moffitt Cancer Center and Research
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, Michigan
Harper Hospital
Detroit, Michigan, United States, 48201
United States, New Jersey
VA New Jersey Health Care Medical Center
East Orange, New Jersey, United States, 07018
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4690, SR259075
Study First Received:	October 11, 2004
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00094081 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

squamous cell carcinoma
oropharynx
oral cavity
larynx
hypopharynx

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Epidermoid Carcinoma

Tirapazamine
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents

Therapeutic Uses
Head and Neck Neoplasms
Physiological Effects of Drugs
Tirapazamine
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009