Clinical Trial: Concomitant Radiation and Cisplatin with and without Tirapazamine in Treatment of Advanced Head and Neck Cancer


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Sponsored by:	Sanofi-Synthelabo
Information provided by:	Sanofi-Synthelabo

Condition	Treatment or Intervention	Phase
Head and Neck Neoplasms	Drug: Cisplatin, Tirapazamine Procedure: Radiation Therapy	Phase III

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

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Arizona
Foundation for Cancer Research and Education, Phoenix, Arizona, 85013, United States; Recruiting

Terry Thomas, MS 602-274-4484 theresa@azoncol0.comgy
David Bachman, MD 602-406-3170 dbrachman@azoncol0.comgy
David Brachman, MD, Principal Investigator

California
Stanford University Medical Center, Palo Alto, California, 94305, United States; Recruiting

Sherie Budenz 650-724-6626
Harlan Pinto, MD, Principal Investigator

Florida
H-Lee Moffitt Cancer Center and Research, Tampa, Florida, 33612, United States; Recruiting

Andy Trotti, MD 813-972-8424
Andrea Trotti, MD, Principal Investigator

Illinois
University of Chicago Medical Center, Chicago, Illinois, 60637, United States; No longer recruiting

Maryland
Johns Hopkins Hospital, Baltimore, Maryland, 21231, United States; Recruiting

Larry Korman 410-614-3158
Ding-Jen Lee, MD 410-955-8062
Ding-Jen Lee, MD, Principal Investigator

Michigan
Harper Hospital, Detroit, Michigan, 48201, United States; Recruiting

Harold Kim, MD 313-745-1538
Harold Kim, MD, Principal Investigator

New Jersey
VA New Jersey Health Care Medical Center, East Orange, New Jersey, 07018, United States; Recruiting

Mary Llorente 973-395-7088
Maryann Sullivan 973-676-1000 Ext. 2093
Basil Kasimis, MD, Principal Investigator

New York
University of Rochester Medical Center, Rochester, New York, 14620, United States; Recruiting

Joy Anderson, MD 585-341-3750 joy_anderson@urmc.rochester.edu
Joy Anderson, MD, Principal Investigator

South Carolina
Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting

Betsy Sass 843-792-6325
Anand Sharma, MD, Principal Investigator

Virginia
Eastern Virginia Medical School, Norfolk, Virginia, 23507, United States; Recruiting

Shankar Giri 757-668-2075
Shankar Giri, MD, Principal Investigator