Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017459
• Other study ID #: SANOFI-EFC3675
• Secondary ID: CDR0000068690
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2001
• Last updated: August 1, 2013
• Start date: July 2000
• Est. completion date: February 2004

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective with or without tirapazamine in treating non-small cell lung cancer

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• tirapazamine

• vinorelbine tartrate

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Arlington-Fairfax Hematology/Oncology, PC	Arlington	Virginia
United States	Dreyer Medical Clinic	Aurora	Illinois
United States	Lone Star Oncology	Austin	Texas
United States	Hematology-Oncology Clinic	Baton Rouge	Louisiana
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Brookdale University Hospital and Medical Center	Brooklyn	New York
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Center for Oncology Research and Treatment, Medical City Hospital	Dallas	Texas
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Northwest Oncology and Hematology, S.C.	Elk Grove Village	Illinois
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	Capitol Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Watson Clinic	Lakeland	Florida
United States	North Penn Hospital	Lansdale	Pennsylvania
United States	Medical Oncology Internal Medicine	Los Angeles	California
United States	Tower Hematology Oncology Medical Group	Los Angeles	California
United States	Southwest Cancer Center at University Medical Center	Lubbock	Texas
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Western Montana Clinic	Missoula	Montana
United States	Cancer Care Center	New Albany	Indiana
United States	Bay Area Tumor Institute	Oakland	California
United States	Ocala Oncology Center	Ocala	Florida
United States	Ocala Research Institute, Inc	Ocala	Florida
United States	Medical Oncology Care Associates	Orange	California
United States	Fox Chase - Temple Cancer Center	Philadelphia	Pennsylvania
United States	Interlakes Oncology/Hematology PC	Rochester	New York
United States	Rockford Clinic	Rockford	Illinois
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	Baptist Health System Cancer Program	San Antonio	Texas
United States	Cancer Therapy Research Center	San Antonio	Texas
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	John Wayne Cancer Institute	Santa Monica	California
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	Los Angeles County Harbor-UCLA Medical Center	Torrance	California
United States	New York Medical College	Valhalla	New York
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Washington Cancer Institute	Washington	District of Columbia
United States	Medical Oncology-Hematology Consultants, P.A.	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States,