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

August 1, 2013 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
      • Los Angeles, California, United States, 90067
        • Medical Oncology Internal Medicine
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
      • Orange, California, United States, 92668
        • Medical Oncology Care Associates
      • San Francisco, California, United States, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Torrance, California, United States, 90509
        • Los Angeles County Harbor-UCLA Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19808
        • Medical Oncology-Hematology Consultants, P.A.
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Science Center - Jacksonville
      • Lakeland, Florida, United States, 33804-5000
        • Watson Clinic
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Ocala, Florida, United States, 34471
        • Ocala Research Institute, Inc
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Dreyer Medical Clinic
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Elk Grove Village, Illinois, United States, 60007
        • Northwest Oncology and Hematology, S.C.
      • Rockford, Illinois, United States, 61103
        • Rockford Clinic
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Hematology-Oncology Clinic
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Clinic
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
    • Montana
      • Missoula, Montana, United States, 59803
        • Western Montana Clinic
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
    • New York
      • Brooklyn, New York, United States, 11212
        • Brookdale University Hospital and Medical Center
      • Rochester, New York, United States, 14623
        • Interlakes Oncology/Hematology PC
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Ohio
      • Akron, Ohio, United States, 44302
        • Akron General Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446-1200
        • North Penn Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Fox Chase - Temple Cancer Center
    • Texas
      • Austin, Texas, United States, 78759
        • Lone Star Oncology
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment, Medical City Hospital
      • Lubbock, Texas, United States, 79415
        • Southwest Cancer Center at University Medical Center
      • San Antonio, Texas, United States, 78205
        • Baptist Health System Cancer Program
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy Research Center
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arlington-Fairfax Hematology/Oncology, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Chair: Elwyn Y. Loh, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

February 13, 2004

First Posted (Estimate)

February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SANOFI-EFC3675
  • CDR0000068690 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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