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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075751 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more tumor cells by making the cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer that has not been previously treated with chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: bortezomib Drug: carboplatin Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) |
| Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive bortezomib alone on the above schedule for up to 1 year at the discretion of the treating physician.
Patients are followed every 6 months for up to 3 years after registration.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study within 5 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
One of the following disease stages:
Measurable or nonmeasurable disease by CT scan, MRI, or x-ray
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36607 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | |
| Loma Linda, California, United States, 92357 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital) | |
| Hines, Illinois, United States, 60141 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71101-4295 | |
| United States, Massachusetts | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Providence Cancer Institute at Providence Hospital | |
| Southfield, Michigan, United States, 48075 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| St. Louis University Hospital Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428-1002 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97201-3098 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38104 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4095 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Veterans Affairs Medical Center - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78229 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| Investigator: | Angela Davies, MD | University of California, Davis |
| Investigator: | Primo N. Lara, MD | University of California, Davis |
More Information
| Study ID Numbers: | CDR0000349336, SWOG-S0339 |
| Study First Received: | January 9, 2004 |
| Last Updated: | January 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075751 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Bortezomib Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |