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

http://www.clinicaltrials.gov/ct/show/NCT00075751?amp;order=6

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

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

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

Location and Contact Information

Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013

Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting

Thomas P. Miller, MD 520-626-2667

CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting

David Kyle King, MD, FACP 602-258-4875 david.king@baannerhealth.com

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting

Thomas Dale Kummet, MD 602-277-5551

Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting

Thomas P. Miller, MD 520-792-1450 ext. 16631

Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting

Laura Fulper Hutchins, MD 501-686-8511 HutchinsLauraF@uams.edu

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, 72205, United States; Recruiting

Bart Barlogie, MD 501-526-2873

California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting

Joseph Szumowski, MD 510-465-8570

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting

Ian C. Anderson, MD 707-521-3859

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, 92868, United States; Recruiting

Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu

City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting

Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org

David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting

Kevin P. Ryan, MD 707-423-5129 ryan_k@comcast.net

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting

Heinz-Josef Lenz, MD 323-865-3955

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting

David R. Gandara, MD 925-372-2064

Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting

Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu

District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting

Lucile L. Adams-Campbell, PhD 202-806-7697

Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting

Raoul Salup, MD 813-972-7579 raoul.salup@med.va.gov

Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting

Thomas E. Seay, MD, PhD 404-851-2340

Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting

Brian F. Issell, MD 808-586-3013 brian@crch.hawaii.edu

Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting

Patrick J. Stiff, MD 708-327-3148

CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting

James L. Wade, MD 217-876-6617

MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting

Lawrence E. Feldman, MD 312-335-3614

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting

Thomas E. Lad, MD 312-996-2046

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, 60141, United States; Recruiting

Nirmala Bhoopalam, MD 708-202-2782

Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting

Shaker R. Dakhil, MD 316-268-5784

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting

Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu

Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting

Shaker R. Dakhil, MD 316-685-2221

Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting

Michael A. Doukas, MD 859-257-4500

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting

Michael A. Doukas, MD 859-281-4956

Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting

Glenn M. Mills, MD 318-675-7639 gmills@lsuhsc.edu

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting

Jill Gilbert, MD 504-568-5151 jgilbe@lsuhsc.edu

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting

Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting

Alan M. Miller, MD, PhD 504-589-5250

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71130, United States; Recruiting

Glenn M. Mills, MD 318-221-8411

Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting

Douglas V. Faller, MD, PhD 617-638-8000

Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting

Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org

CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting

David A. Decker, MD 248-551-7695 ddecker@beaumont.edu

CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting

Kathleen Jo Yost, MD 616-391-1230 kathleen.yost@grcop.org

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting

Philip J. Stella, MD 877-590-5995

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, 48202, United States; Recruiting

Robert Anthony Chapman, MD 313-916-1850 rchapma1@hfhs.org

Providence Cancer Institute at Providence Hospital, Southfield, Michigan, 48075, United States; Recruiting

Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0912, United States; Recruiting

Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, 48105, United States; Recruiting

Laurence H. Baker, DO, FACOI 734-769-7100

Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting

Lawrence E. Flaherty, MD 313-576-1000

Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting

James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, 39531-2410, United States; Recruiting

Robert Woody Veith, MD 504-568-5151

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting

James Tate Thigpen, MD 601-362-4471

Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting

John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net

CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting

Jorge C. Paradelo, MD 816-823-0555 kccop@kccop.org

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting

Patrick H. Henry, MD 314-569-6573

St. Louis University Hospital Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting

Paul J. Petruska, MD 314-577-8854 petruspj@slu.edu

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States; Recruiting

Sarah A. Taylor, MD 816-861-4700 ext. 491

Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting

Patrick W. Cobb, MD 406-259-2245

New Jersey
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018-1095, United States; Recruiting

Patricia E. Gilhooly, MD 973-676-1000 ext. 3966 patricia.gilhooly@med.va.gov

New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting

Cheryl L. Willman, MD 505-272-5837

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting

Douglas A. Clark, MD 505-243-4039 clark.douglas@albuquerque.va.gov

New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting

Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting

Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, 10016, United States; Recruiting

Amy D. Tiersten, MD 212-652-1916

Veterans Affairs Medical Center - Albany, Albany, New York, 12208, United States; Recruiting

James Arthur Holland, MD 518-462-3311 ext. 2328 james.holland3@med.va.gov

North Carolina
CCOP - Southeast Cancer Control Consortium, Winston Salem, North Carolina, 27104-4241, United States; Recruiting

James N. Atkins, MD 336-777-3036

Veterans Affairs Medical Center - Salisbury, Salisbury, North Carolina, 28144, United States; Recruiting

Joel A. Thurm, MD 704-638-9000 ext. 4176

Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting

J. Philip Kuebler, MD, PhD 614-443-2267

CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting

Howard M. Gross, MD 937-832-1093

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting

Abdul-Rahman Jazieh, MD, MPH 513-584-3830

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting

George Thomas Budd, MD 216-444-6480

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting

Abdul-Rahman Jazieh, MD, MPH 513-861-3100 ext. 6537

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting

Howard M. Gross, MD 937-268-6511

Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting

Craig R. Nichols, MD 503-494-6346

CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting

Keith S. Lanier, MD 503-216-6260

Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting

Craig R. Nichols, MD 503-220-8262

South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting

Jeffrey Kent Giguere, MD 864-241-6251

CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting

James Dewitt Bearden, MD 864-560-6812

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting

Carolyn E. Reed, MD 843-792-3362 reedce@musc.edu

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting

Carolyn E. Reed, MD 843-789-7865

Tennessee
University of Tennessee Cancer Institute, Memphis, Tennessee, 38104, United States; Recruiting

Mohammad Jahanzeb, MD 901-722-0532

Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting

Mitchell A. Garrison, MD 210-916-0504 mitchell.garrison@cen.amedd.army.mll

CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting

Lucas Wong, MD 254-724-7048 lwong@swmail.sw.org

Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting

James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org

University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030-4095, United States; Recruiting

Scott Michael Lippman, MD, FACP 713-745-3672

University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting

Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu

University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting

Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu

Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting

William R. Robinson, MD 806-355-9703

Veterans Affairs Medical Center - Houston, Houston, Texas, 77030, United States; Recruiting

Gauri Varadhachary, MD 713-791-1414 ext. 5340

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting

Geoffrey R. Weiss, MD 210-617-5186

Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting

Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809

Utah
Huntsman Cancer Institute, Salt Lake City, Utah, 84112-5550, United States; Recruiting

Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting

Wolfram Samlowski, MD 801-582-1565

Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting

Lauren Kenneth Colman, MD 253-403-1461

CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting

Andrew David Jacobs, MD 206-341-0446

Madigan Army Medical Center, Tacoma, Washington, 98431-5000, United States; Recruiting

Rajat Bannerji, MD, PhD 253-968-2504

Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting

William H. Schubach, MD 206-764-2265

Canada, Ontario
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Recruiting

Alberto S. Pappo, MD 416-813-6594 alberto.pappo@sickkids.ca

** POSTED MAY 2004 ***