Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer

Sponsoren

Hauptsponsor: Southwest Oncology Group

Mitarbeiter: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for non-small cell lung cancer.

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

detaillierte Beschreibung

OBJECTIVES:

- Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer.

- Compare response rates in patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to weight loss (less than 5% vs 5% or more), stage of disease (IIIB vs IV), and lactate dehydrogenase level (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.

- Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for one year, and then every 6 months for 2 years, or until death.

PROJECTED ACCRUAL: Approximately 500 patients (250 per arm) will be accrued for this study within 20 months.

Gesamtstatus Completed
Anfangsdatum November 2000
Fertigstellungstermin April 2006
Phase Phase 3
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: carboplatin

Interventionsart: Drug

Interventionsname: paclitaxel

Interventionsart: Drug

Interventionsname: tirapazamine

Teilnahmeberechtigung

Kriterien:

DISEASE CHARACTERISTICS:

- Histologically or cytologically proven newly diagnosed advanced primary non-small cell lung cancer (NSCLC), including the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified carcinoma OR

- Recurrent disease after prior surgery and/or radiotherapy

- Stage IIIB disease

- T4 lesion due to malignant pleural effusion OR

- Stage IV disease

- Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the ipsilateral lung)

- Measurable or evaluable disease

- Pleural effusions, ascites, and laboratory parameters not considered as only evidence of disease

- Must be outside prior radiated field or area of prior surgical resection or new lesion must be present

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

Renal:

- Creatinine no greater than ULN

- Creatinine clearance at least 50 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No peripheral neuropathy (motor or sensory) of grade 2 or greater

- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy for NSCLC

Chemotherapy:

- No prior systemic chemotherapy for NSCLC

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 2 weeks since prior thoracic or other major surgery and recovered

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Stephen K. Williamson, MD Study Chair University of Kansas
Ort
Einrichtung:
MBCCOP - Gulf Coast | Mobile, Alabama, 36688, United States
CCOP - Greater Phoenix | Phoenix, Arizona, 85006-2726, United States
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson | Tucson, Arizona, 85723, United States
Arizona Cancer Center | Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences | Little Rock, Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas, 72205, United States
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California, 91010-3000, United States
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California, 90095-1781, United States
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California, 94553, United States
CCOP - Bay Area Tumor Institute | Oakland, California, 94609-3305, United States
Chao Family Comprehensive Cancer Center | Orange, California, 92868, United States
University of California Davis Cancer Center | Sacramento, California, 95817, United States
UCSF Cancer Center and Cancer Research Institute | San Francisco, California, 94143-0128, United States
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California, 95403, United States
David Grant Medical Center | Travis Air Force Base, California, 94535, United States
University of Colorado Cancer Center | Denver, Colorado, 80010, United States
Veterans Affairs Medical Center - Denver | Denver, Colorado, 80220, United States
CCOP - Atlanta Regional | Atlanta, Georgia, 30342-1701, United States
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia, 30905-5650, United States
Cancer Research Center of Hawaii | Honolulu, Hawaii, 96813, United States
MBCCOP - University of Illinois at Chicago | Chicago, Illinois, 60612-7323, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois, 60612, United States
CCOP - Central Illinois | Decatur, Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois, 60141, United States
Loyola University Medical Center | Maywood, Illinois, 60153, United States
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa, 52722, United States
University of Kansas Medical Center | Kansas City, Kansas, 66160-7357, United States
CCOP - Wichita | Wichita, Kansas, 67214-3882, United States
Veterans Affairs Medical Center - Wichita | Wichita, Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky, 40511-1093, United States
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky, 40536-0084, United States
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine | New Orleans, Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana, 71130-3932, United States
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana, 71130, United States
Boston Medical Center | Boston, Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan, 48105, United States
CCOP - Ann Arbor Regional | Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109-0752, United States
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201-1379, United States
Veterans Affairs Medical Center - Detroit | Detroit, Michigan, 48201-1932, United States
Henry Ford Hospital | Detroit, Michigan, 48202, United States
Providence Hospital - Southfield | Southfield, Michigan, 48075-9975, United States
CCOP - Duluth | Duluth, Minnesota, 55805, United States
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi, 39531-2410, United States
University of Mississippi Medical Center | Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi, 39534-2576, United States
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri, 64128, United States
CCOP - Kansas City | Kansas City, Missouri, 64131, United States
St. Louis University Health Sciences Center | Saint Louis, Missouri, 63110-0250, United States
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium | Billings, Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico, 87108-5138, United States
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico, 87131, United States
Veterans Affairs Medical Center - Albany | Albany, New York, 12208, United States
Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States
University of Rochester Medical Center | Rochester, New York, 14642, United States
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina, 27104-4241, United States
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio, 45220-2288, United States
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio, 45267-0502, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
CCOP - Columbus | Columbus, Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton | Dayton, Ohio, 45428, United States
CCOP - Dayton | Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio, 43623-3456, United States
Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma, 73104, United States
Oregon Cancer Center | Portland, Oregon, 97201-3098, United States
Veterans Affairs Medical Center - Portland | Portland, Oregon, 97207, United States
CCOP - Columbia River Program | Portland, Oregon, 97213, United States
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina, 29401-5799, United States
Medical University of South Carolina | Charleston, South Carolina, 29425-0721, United States
CCOP - Greenville | Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina | Spartanburg, South Carolina, 29303, United States
Brooke Army Medical Center | Fort Sam Houston, Texas, 78234, United States
University of Texas Medical Branch | Galveston, Texas, 77555-0209, United States
Veterans Affairs Medical Center - Houston | Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio | San Antonio, Texas, 78284-7811, United States
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas, 78284, United States
Veterans Affairs Medical Center - Temple | Temple, Texas, 76504, United States
CCOP - Scott and White Hospital | Temple, Texas, 76508, United States
Huntsman Cancer Institute | Salt Lake City, Utah, 84112, United States
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah, 84148, United States
CCOP - Virginia Mason Research Center | Seattle, Washington, 98101, United States
Swedish Cancer Institute | Seattle, Washington, 98104, United States
Veterans Affairs Medical Center - Seattle | Seattle, Washington, 98108, United States
CCOP - Northwest | Tacoma, Washington, 98405-0986, United States
Madigan Army Medical Center | Tacoma, Washington, 98431-5000, United States
Standort Länder

United States

Überprüfungsdatum

January 2002

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov