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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094081
• Other study ID #: EFC4690
• Secondary ID: SR259075
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2004
• Last updated: February 12, 2010
• Start date: October 2002
• Est. completion date: September 2006

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 861
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• tirapazamine (SR259075)

• cisplatin

Procedure:
• Radiation Therapy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Harper Hospital	Detroit	Michigan
United States	VA New Jersey Health Care Medical Center	East Orange	New Jersey
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Stanford University Medical Center	Palo Alto	California
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	University of Rochester Medical Center	Rochester	New York
United States	H-Lee Moffitt Cancer Center and Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival.
Secondary	Time to locoregional failure.