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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
Not Enrolling
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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Elwyn Y. Loh, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




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



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