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Lung CancerPhase 3NCT00017459

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

A Phase 3 study testing cisplatin, tirapazamine and vinorelbine tartrate in people with Lung Cancer, run by Sanofi at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, tirapazamine and vinorelbine tartrate
How many people
Not given
Where
42 sitesUnited States
Study dates
Jul 2000to Feb 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Arlington-Fairfax Hematology/Oncology, PC

    Arlington, Virginia, 22205

  • Dreyer Medical Clinic

    Aurora, Illinois, 60506

  • Lone Star Oncology

    Austin, Texas, 78759

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Center for Oncology Research and Treatment, Medical City Hospital

    Dallas, Texas, 75230

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Northwest Oncology and Hematology, S.C.

    Elk Grove Village, Illinois, 60007

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Watson Clinic

    Lakeland, Florida, 33804-5000

  • North Penn Hospital

    Lansdale, Pennsylvania, 19446-1200

  • Tower Hematology Oncology Medical Group

    Los Angeles, California, 90048

  • Medical Oncology Internal Medicine

    Los Angeles, California, 90067

  • Southwest Cancer Center at University Medical Center

    Lubbock, Texas, 79415

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Western Montana Clinic

    Missoula, Montana, 59803

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Ocala Research Institute, Inc

    Ocala, Florida, 34471

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Medical Oncology Care Associates

    Orange, California, 92668

  • Fox Chase - Temple Cancer Center

    Philadelphia, Pennsylvania, 19140

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • Rockford Clinic

    Rockford, Illinois, 61103

  • Baptist Health System Cancer Program

    San Antonio, Texas, 78205

  • Cancer Therapy Research Center

    San Antonio, Texas, 78229

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • Los Angeles County Harbor-UCLA Medical Center

    Torrance, California, 90509

  • New York Medical College

    Valhalla, New York, 10595

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Medical Oncology-Hematology Consultants, P.A.

    Wilmington, Delaware, 19808

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
cisplatin, tirapazamine, vinorelbine tartrate
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

  • tirapazamineDrug

  • vinorelbine tartrateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2004 (estimated)
  2. Study startJul 2000
  3. Study completionFeb 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017459
Sponsor's protocol ID
SANOFI-EFC3675
Other IDs
CDR0000068690
Status last verified
Feb 2010
First submitted
6 Jun 2001
Last updated
2 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, tirapazamine and vinorelbine tartrate in people with Lung Cancer, run by Sanofi at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00017459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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