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

NCT00017459 | Completed Phase 3

• 2 other identifiers: SANOFI-EFC3675CDR0000068690
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 42

Brief 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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

cisplatin DRUG

tirapazamine DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (42)

Tower Hematology Oncology Medical Group

Los Angeles, California, 90048, United States

Location

Medical Oncology Internal Medicine

Los Angeles, California, 90067, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Medical Oncology Care Associates

Orange, California, 92668, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Los Angeles County Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Medical Oncology-Hematology Consultants, P.A.

Wilmington, Delaware, 19808, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Watson Clinic

Lakeland, Florida, 33804-5000, United States

Location

Ocala Research Institute, Inc

Ocala, Florida, 34471, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Dreyer Medical Clinic

Aurora, Illinois, 60506, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Northwest Oncology and Hematology, S.C.

Elk Grove Village, Illinois, 60007, United States

Location

Rockford Clinic

Rockford, Illinois, 61103, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Hematology-Oncology Clinic

Baton Rouge, Louisiana, 70808, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Western Montana Clinic

Missoula, Montana, 59803, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

North Penn Hospital

Lansdale, Pennsylvania, 19446-1200, United States

Location

Fox Chase - Temple Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Southwest Cancer Center at University Medical Center

Lubbock, Texas, 79415, United States

Location

Baptist Health System Cancer Program

San Antonio, Texas, 78205, United States

Location

Cancer Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

Arlington-Fairfax Hematology/Oncology, PC

Arlington, Virginia, 22205, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Tirapazamine; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Elwyn Y. Loh, MD

  Sanofi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: February 16, 2004
• Study Start: July 1, 2000
• Study Completion: February 1, 2004
• Last Updated: August 2, 2013

Record last verified: 2010-02

Locations

US (42)