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The International Tirazone Triple Trial (i3T): A Phase III, Randomized Efficacy And Safety Study Of The Combination Chemotherapy With Tirapazamine+Cisplatin+Vinorelbine Versus Cisplatin+Vinorelbine In Subjects With Inoperable, Previously Untreated, Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

The International Tirazone Triple Trial (i3T): A Phase III, Randomized Efficacy And Safety Study Of The Combination Chemotherapy With Tirapazamine+Cisplatin+Vinorelbine Versus Cisplatin+Vinorelbine In Subjects With Inoperable, Previously Untreated, Non-Small Cell Lung Cancer


OBJECTIVES: I. Compare the overall survival duration of patients with stage IIIB or IV
non-small cell lung cancer treated with vinorelbine and cisplatin with or without
tirapazamine. II. Compare the complete and partial response rates, time to disease
progression, and time to treatment failure in these patients treated with these regimens.
III. Compare the clinical benefit of these regimens, in terms of performance status and body
weight, in these patients. IV. Compare the toxicity and safety of these regimens in these
patients. V. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms. Arm I: Patients receive tirapazamine IV over 2 hours followed by cisplatin
IV over 1 hour on day 1. Patients also receive vinorelbine IV over 6-10 minutes on days 1,
8, 15, and 22. Arm II: Patients receive cisplatin and vinorelbine as in arm I. Treatment
repeats every 28 days for a total of 6 courses in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed at baseline, during each course of
treatment, at 30 days after the last course of treatment, and then every 8 weeks for 2-3
years. Patients are followed every 8 weeks for 2-3 years.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Stage IIIB or IV Newly diagnosed or recurrent disease Measurable lesions At
least 10 mm by spiral CT scan OR At least 20 mm by conventional techniques Previously
irradiated lesions are considered measurable provided they progressed or appeared after
completion of radiotherapy The following are considered nonmeasurable: Pleural or
pericardial effusions Cystic lesions Lymphangitis pulmonis Bony x-ray abnormalities
Abnormal scans with nonmeasurable filling defects No symptomatic brain metastasis or CNS
involvement by CT scan or MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit
of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine normal Other: No other
malignancy within the past 5 years except adequately treated carcinoma in situ of the
cervix or basal cell carcinoma that is not likely to recur No history of allergic
reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) used on this study Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for
NSCLC Chemotherapy: No prior chemotherapy for NSCLC No prior platinum-based chemotherapy
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior
radiotherapy to potential indicator lesion(s) At least 4 weeks since prior radiotherapy
and recovered Surgery: Recovered from prior surgical procedure(s) Other: At least 30 days
since prior investigational drug

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Elwyn Y. Loh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sanofi

Authority:

United States: Federal Government

Study ID:

CDR0000068690

NCT ID:

NCT00017459

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
Fox Chase - Temple Cancer Center Philadelphia, Pennsylvania  19111-2442
New York Medical College Valhalla, New York  10595
Akron General Medical Center Akron, Ohio  44302
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
John Wayne Cancer Institute Santa Monica, California  90404
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Rockford Clinic Rockford, Illinois  61103
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Brookdale University Hospital and Medical Center Brooklyn, New York  11212
Capitol Comprehensive Cancer Care Clinic Jefferson City, Missouri  65109
Interlakes Oncology/Hematology PC Rochester, New York  14623
Ocala Oncology Center Ocala, Florida  34474
North Penn Hospital Lansdale, Pennsylvania  19446-1200
Lone Star Oncology Austin, Texas  78759
University of Florida Health Science Center - Jacksonville Jacksonville, Florida  32209
Northwest Oncology and Hematology, S.C. Elk Grove Village, Illinois  60007
Washington Cancer Institute Washington, District of Columbia  20010
Cancer Care Center New Albany, Indiana  47150
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Watson Clinic Lakeland, Florida  33805
Tower Hematology Oncology Medical Group Los Angeles, California  90048
Center for Oncology Research and Treatment, Medical City Hospital Dallas, Texas  75230
Medical Oncology Internal Medicine Los Angeles, California  90067
Bay Area Tumor Institute Oakland, California  94609
Medical Oncology Care Associates Orange, California  92668
Dreyer Medical Clinic Aurora, Illinois  60506
Baptist Health System Cancer Program San Antonio, Texas  78205
Western Montana Clinic Missoula, Montana  59807-7609
Los Angeles County Harbor-UCLA Medical Center Torrance, California  90509
Medical Oncology-Hematology Consultants, P.A. Wilmington, Delaware  19808
Ocala Research Institute, Inc Ocala, Florida  34471
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Hematology-Oncology Clinic Baton Rouge, Louisiana  70808
Southwest Cancer Center at University Medical Center Lubbock, Texas  79415
Cancer Therapy Research Center San Antonio, Texas  78229
Arlington-Fairfax Hematology/Oncology, PC Arlington, Virginia  22205