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Home > "G" Clinical Trials Conditions > Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer



Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 recurrentnon-small cell lung cancer that has not been previously treated with chemotherapy.
Details: OBJECTIVES: Primary - Determine the overall survival of patients with chemotherapy-naïve advanced or recurrent non-small cell lung cancer treated with gemcitabine, carboplatin, and bortezomib. Secondary - Determine the response rate (confirmed and unconfirmed, complete and partial) and progression-free survival of patients with measurable disease treated with this regimen. - Determine the quantitative toxic effects of this regimen in these patients. - Correlate levels of hypoxia-induced secreted proteins and tumor DNA in plasma, levels of apoptosis-associated proteins in tumor tissue, and the change in levels of bortezomib-modulated proteins in peripheral white blood cells with response and survival of patients treated with this regimen. 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - One of the following disease stages: - Selected stage IIIB (T4 due to malignant pleural effusion) - Stage IV - Recurrent disease after prior surgery and/or radiotherapy - Measurable or nonmeasurable disease by CT scan, MRI, or x-ray - No pleural effusions, ascites, or laboratory parameters as the only evidence of disease - Disease must be outside the prior radiation field or a new lesion formed inside the port - No known brain metastases - Must be offered participation in SWOG-S9925 PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - SGOT or SGPT 2.5 times upper limit of normal - Bilirubin normal Renal - Creatinine normal OR - Creatinine clearance 60 mL/min Other - Not pregnant or nursing - Fertile patients must use effective contraception - No known hypersensitivity to boron, mannitol, or bortezomib - No greater than grade 1 peripheral neuropathy - 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 adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic agents for NSCLC - No concurrent biologic agents Chemotherapy - No prior systemic chemotherapy for NSCLC - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 2 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 Other - No other concurrent anticancer agents - No other concurrent investigational drugs - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AngelaDavies,  ,  University of California Davis Cancer Center

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4095
United States
Recruiting Scott  Lippman 713-745-3672

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle,  Washington,  98104
United States
Recruiting Saul  Rivkin 206-386-2929

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting David  Fishman 312-926-7365

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195-9001
United States
Recruiting George  Budd 216-444-6480

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Veterans Affairs Medical Center - Memphis *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

David Grant Medical Center *Recruiting*
Travis Air Force Base,  California,  94535
United States
Recruiting David  Gandara 707-423-7300

Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City,  Utah,  84148
United States
Recruiting Wolfram  Samlowski 801-582-1565

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

Tripler Army Medical Center *Recruiting*
Honolulu,  Hawaii,  96859-5000
United States
Recruiting Brian  Issell 808-433-4089

CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa,  California,  95403
United States
Recruiting Ian  Anderson 707-521-3859

Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez,  California,  94553
United States
Recruiting David  Gandara 925-372-2064

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix,  Arizona,  85012
United States
Recruiting Thomas  Kummet 602-277-5551

Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130-3932
United States
Recruiting Glenn  Mills 318-675-7639

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting Abdul-Rahman  Jazieh 513-861-3100 ext. 6537

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

CCOP - Atlanta Regional *Recruiting*
Atlanta,  Georgia,  30342-1701
United States
Recruiting Thomas  Seay 404-851-2340

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48105
United States
Recruiting Laurence  Baker 734-769-7100

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0912
United States
Recruiting Laurence  Baker 734-936-3983

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Randall  Holcombe 714-456-5153

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-587-7566

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0565
United States
Recruiting Robert  Whitehead 409-772-1164

Veterans Affairs Medical Center - Boston (Jamaica Plain) *Recruiting*
Jamaica Plain,  Massachusetts,  02130
United States
Recruiting Michelle  Hankins 617-232-9500

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anibal  Drelichman 313-552-0620

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Eastern Virginia Medical School *Recruiting*
Norfolk,  Virginia,  23510-1115
United States
Recruiting Paul  Schellhammer 804-628-2409

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Joseph  Szumowski 510-465-8570

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bearden 864-560-7050

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting William  Schubach 206-764-2265

Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque,  New Mexico,  87108-5138
United States
Recruiting Douglas  Clark 505-243-4039

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting David  Decker 248-551-7695

Veterans Affairs Medical Center - Temple *Recruiting*
Temple,  Texas,  76504
United States
Recruiting Phalguni  Mukhopadhyay 254-778-4811 ext. 4809

Baylor College of Medicine *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Seth  Lerner 713-798-5906

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97201-3098
United States
Recruiting Craig  Nichols 503-494-6346

Brooke Army Medical Center *Recruiting*
Fort Sam Houston,  Texas,  78234-6200
United States
Recruiting Mitchell  Garrison 210-916-0504

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36607
United States
Recruiting Paul  Schwarzenberger 251-544-1013

Southwest Cancer Center at UMC *Recruiting*
Lubbock,  Texas,  79415-3364
United States
Recruiting Werner  W. DeRiese 806-775-8590

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112-5550
United States
Recruiting Wolfram  Samlowski 801-585-0255

CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Patrick  Henry 314-569-6573

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1461

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7353
United States
Recruiting Sarah  Taylor 913-588-6029

Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-589-5250

Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-270-0501

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130
United States
Recruiting Glenn  Mills 318-221-8411

Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Geoffrey  Weiss 210-617-5120

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Anthony  Elias 720-848-1622

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton,  Ohio,  45428-1002
United States
Recruiting Howard  Gross 937-268-6511

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153-5500
United States
Recruiting Patrick  Stiff 708-327-3148

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Peter  Carroll 415-221-4810

Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit,  Michigan,  48201-1932
United States
Recruiting Lawrence  Flaherty 313-576-1000

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Carolyn  Reed 843-789-7865

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Patrick  Williams 253-968-2505

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Douglas  Faller 617-638-8000

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-0269
United States
Recruiting Kim  Margolin 626-359-8111

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines,  Illinois,  60141
United States
Recruiting Nirmala  Bhoopalam 708-202-2782

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Lawrence  Flaherty 313-745-9155

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Patrick  Cobb 406-259-2245

Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson,  Arizona,  85723
United States
Recruiting Thomas  Miller 520-792-1450 ext. 16631

Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington,  Kentucky,  40502-2236
United States
Recruiting Michael  Doukas 859-281-4956

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Paul  Petruska 314-577-8854

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cheryl  Willman 505-272-5837

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting John  Barstis 310-825-5268

Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson,  Mississippi,  39216
United States
Recruiting James  Thigpen 601-362-4471

Western New York Urology Associates *Recruiting*
Buffalo,  New York,  14220
United States
Recruiting Scott  Perrapato 716-828-3369

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Thomas  Miller 520-626-2667

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Michael  Doukas 859-257-4500

Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City,  Missouri,  64128
United States
Recruiting Sarah  Taylor 816-861-4700 ext. 491

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Edith  Perez 904-953-0118

Veterans Affairs Medical Center - Portland *Recruiting*
Portland,  Oregon,  97207
United States
Recruiting Craig  Nichols 503-220-8262

Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Bart  Barlogie 501-526-2873

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Laura  Hutchins 501-686-8511

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0501
United States
Recruiting Abdul-Rahman  Jazieh 513-584-3830

Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Steven  Grunberg 802-847-8400

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting David  Schuller 614-293-4878

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Geoffrey  Weiss 210-617-5120

CCOP - Virginia Mason Research Center *Recruiting*
Seattle,  Washington,  98101
United States
Recruiting Andrew  Jacobs 206-341-0446


Additional Information:
Study ID Numbers:
  CDR0000349336;  SWOG-S0339
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075751

Other Stage 4 Non-Small Cell Lung Cancer Studies:
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2. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors

3. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

4. Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

5. Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed

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