Not Signed In -
Oxaliplatin Injection |
Eloxatin |
Clinical Trial: Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-small Cell Lung Cancer (NSCLC)
This study is currently recruiting patients.
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Purpose
The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: Gemcitabine/Oxaliplatin (GEMOX) Drug: Carboplatin/Paclitaxel (CP) | Phase III |
MedlinePlus related topics: Cancer; Lung Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) versus Carboplatin/Paclitaxel (CP) as First-line Therapy in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)
Further Study Details:
Expected Total Enrollment: 480
Study start: March 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
- One (1) unidimensionally measurable lesion
- ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1
- Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
- Recovery in full from any previous surgical procedure
- No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease
Exclusion Criteria:
- Hypersensitivity to any of the 4 study drugs
- Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
- Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
- History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
- Patient is a pregnant or lactating female
Location and Contact Information
Stephanie Mull 832-601-6475 stephanie.mull@usoncology.com
Sharon Pritchard 214-584-3217 sharon.pritchard@usoncology.com
Sharon Pritchard 214-584-3217 sharon.pritchard@usoncology.com
Alabama
Birmingham Hematology and Oncology Associates, Birmingham, Alabama, 35235, United States; Recruiting
Shaily Lakhanpal, MD 205-838-3070 Shaily.Lakhanpal@usoncology.com
Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama, 35235, United States; Recruiting
Shaily Lakhanpal, MD 205-838-3070 Shaily.Lakhanpal@usoncology.com
Arizona
Arizona Oncology Associates - Hematology Oncology Physicians, Tucson, Arizona, 85704, United States; Recruiting
Donald Brooks, MD 520-797-4468 Donald.Brooks@usoncology.com
Northern Arizona Hematology & Oncology Associates, Sedona, Arizona, 86336, United States; Recruiting
Deborah L. Lindquist, MD 928-204-4163 Deborah.Lindquist@usoncology.com
Hematology Oncology Associates, Phoenix, Arizona, 85012, United States; Recruiting
Michael S. Roberts, MD 602-274-2994 Michael.Roberts@usoncology.com
Colorado
Rocky Mountain Cancer Centers, Denver, Colorado, 80218, United States; Recruiting
Allen L. Cohn, MD 303-388-4876 Allen.Cohn@usoncology.com
Florida
South Florida Oncology & Hematology Consultants, Plantation, Florida, 33324, United States; Recruiting
Allen L. Greenberg, MD 954-370-8585 Allen.Greenberg@usoncology.com
Cancer Centers of Florida, P.A., Ocoee, Florida, 34761, United States; Recruiting
Barry Berman, MD 407-426-8484 Barry.Berman@usoncology.com
Ocala Oncology Center, Ocala, Florida, 34474, United States; Recruiting
Thomas H. Cartwright, MD 352-732-4032 Thomas.Cartwright@usoncology.com
Florida Cancer Institute, New Port Richey, Florida, 34652, United States; Recruiting
Gerald J. Robbins, MD 727-842-8411 Gerald.Robbins@usoncology.com
Illinois
Hematology Oncology Associates of Illinois, Skokie, Illinois, 60077, United States; Recruiting
Ira A. Oliff, MD 847-568-9930 Ira.Oliff@usoncology.com
Northwest Medical Specialists, PC, Niles, Illinois, 60714, United States; Recruiting
Leonard M. Klein, MD 847-827-9060 Leonard.Klein@usoncology.com
Hematology Oncology Associates of Illinois, Chicago, Illinois, 60611, United States; Recruiting
Ann L. Mellott, MD 312-981-5538 Ann.Mellott@usoncology.com
Indiana
Central Indiana Cancer Centers, Indianapolis, Indiana, 46227, United States; Recruiting
David M. Loesch, MD 317-859-5500 David.Loesch@usoncology.com
Iowa
Oncology Associates of Cedar Rapids, Cedar Rapids, Iowa, 52403, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303 Martin.Wiesenfeld@usoncology.com
Kansas
Kansas City Oncology and Hematology Group, Overland Park, Kansas, 66210, United States; Recruiting
Marcus A. Neubauer, MD 913-234-0400 Marcus.Neubauer@usoncology.com
Maryland
Maryland Oncology Hematology, P.A., Columbia, Maryland, 21044, United States; Recruiting
Edward Lee, MD 410-964-2212 Edward.Lee@usoncology.com
Massachusetts
Berkshire Hematology Oncology, PC, Pittsfield, Massachusetts, 01201, United States; Recruiting
Harvey Zimbler, MD 413-496-8205 Harvey.Zimbler@usoncology.com
Minnesota
Minnesota Oncology Hematology, Minneapolis, Minnesota, 55404, United States; Recruiting
Patrick J. Flynn, MD 612-863-8585 Patrick.Flynn@usoncology.com
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, 55404, United States; Recruiting
Patrick J. Flynn, MD 612-863-8585 Patrick.Flynn@usoncology.com
Missouri
Arch Medical Services, Inc., St. Louis, Missouri, 63141, United States; Recruiting
John R. Eckardt, MD 314-628-1210 John.Eckardt@usnoncology.com
Missouri Cancer Associates, Columbia, Missouri, 65201, United States; Recruiting
David M. Schlossman, MD 573-874-7800 David.Schlossman@usoncology.com
Nevada
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89109, United States; Recruiting
Gregory Obara, MD 702-952-3400 Gregory.Obara@usoncology.com
New Mexico
New Mexico Cancer Care Associates, Santa Fe, New Mexico, 87505, United States; Recruiting
Timothy M. Lopez, MD 505-955-7900 Timothy.Lopez@usoncology.com
New York
New York Oncology Hematology, Latham, New York, 12110, United States; Recruiting
Charles Weissman, MD 518-786-3122 charles.weissman@usoncology.com
New York Oncology Hematology, P.C., Albany, New York, 12208, United States; Recruiting
James C. Arseneau, MD 518-489-2607 James.Arseneau@usoncology.com
Interlakes Oncology & Hematology, P.C., Rochester, New York, 14623, United States; Recruiting
Alexander J. Solky, MD 585-350-2300 Alexander.Solky@usoncology.com
New York Oncology Hematology, P.C., Rexford, New York, 12148, United States; Recruiting
Siddique Tai, MD 518-399-4600 Siddique.Tai@usoncology.com
North Carolina
Raleigh Hematology Oncology Clinic, Cary, North Carolina, 27511, United States; Recruiting
William R. Berry, MD 919-852-1994 William.Berry@usoncology.com
Piedmont Hematology Oncology Associates, PLLC., Winston Salem, North Carolina, 27103, United States; Recruiting
Judith O. Hopkins, MD 336-277-8800 Judith.Hopkins@usoncology.com
Ohio
Dayton Oncology & Hematology, P.A., Kettering, Ohio, 45409, United States; Recruiting
Robert N. Raju, MD 937-293-1622 Robert.Raju@usoncology.com
Oklahoma
Cancer Care Associates, Tulsa, Oklahoma, 74136-1902, United States; Recruiting
Mark R. Olsen, MD 918-592-3700 Mark.Olsen@usoncology.com
Cancer Care Associates, Oklahoma City, Oklahoma, 73120, United States; Recruiting
Vikki A. Canfield, MD 405-943-9988 Vikki.Canfield@usoncology.com
Oregon
Willamette Valley Cancer Center, Eugene, Oregon, 97401, United States; Recruiting
Glenn S. Buchanan, MD 541-683-5001 Glenn.Buchanan@usoncology.com
South Carolina
Cancer Centers of the Carolinas, Seneca, South Carolina, 29672, United States; Recruiting
John D. Hunter, MD 864-888-3717 John.Hunter@usoncology.com
Texas
The Texas Cancer Center, Dallas, Texas, 75237, United States; Recruiting
John V. Cox, DO 972-709-2580 John.Cox@usoncology.com
Texas Oncology, P.A., Dallas, Texas, 75246, United States; Recruiting
Joanne Blum, MD 214-370-1000 Joanne.Blum@usoncology.com
Texas Oncology, P.A., Dallas, Texas, 75231, United States; Recruiting
Kristi J. McIntyre, MD 214-739-4175 Kristi.McIntyre@usoncology.com
Texas Cancer Center at Medical City, Dallas, Texas, 75230-2510, United States; Recruiting
Michael A. Savin, MD 972-566-4291 Michael.Savin@usoncology.com
Texas Oncology, P.A., Bedford, Texas, 76022, United States; Recruiting
Thomas C. Anderson, MD 817-359-9033 Thomas.Anderson@usoncology.com
Mamie McFaddin Ward Cancer Center, Beaumont, Texas, 77702-1449, United States; Recruiting
Scott A. McKenney, MD 409-899-7180 Scott.McKenney@usoncology.com
Texas Oncology Cancer Center, Austin, Texas, 78731, United States; Recruiting
John F. Sandbach, MD 512-302-1771 John.Sandbach@usoncology.com
Texas Oncology, P.A., Arlington, Texas, 76012, United States; Recruiting
Sohail Akbani, MD 817-274-6532 Sohail.Akbani@usoncology.com
Texas Cancer Center - Abilene, Abilene, Texas, 79606, United States; Recruiting
Anton Melnyk, MD 325-692-0188 Anton.Melnyk@usoncology.com
Texas Cancer Center of Mesquite, Mesquite, Texas, 75150, United States; Recruiting
Sreeni R. Chittoor, MD 972-686-6411 Sreeni.Chittoor@usoncology.com
South Texas Cancer Center - McAllen, McAllen, Texas, 78503-1298, United States; Recruiting
Billie J. Marek, MD 956-992-0219 Billie.Marek@usoncology.com
Longview Cancer Center, Longview, Texas, 75601, United States; Recruiting
Larry L. Frase, MD 903-757-2122 Larry.Frase@usoncology.com
Lake Vista Cancer Center, Lewisville, Texas, 75067, United States; Recruiting
Michael H. Park, MD 972-459-1300 Michael.Park@usoncology.com
Texas Oncology, P.A., Irving, Texas, 75061-2244, United States; Recruiting
Gerald Edelman, MD 972-256-3537 Gerald.Edelman@usoncology.com
Texas Oncology, P.A., Houston, Texas, 77024, United States; Recruiting
Frankie A. Holmes, MD 713-467-1722 Frankie.Holmes@usoncology.com
Texas Oncology, P.A., Garland, Texas, 75042-5788, United States; Recruiting
Manish Gupta, MD 972-272-3417 Manish.Gupta@usoncology.com
Texas Oncology, P.A., Fort Worth, Texas, 76104, United States; Recruiting
Robert L. Ruxer, MD 817-850-2000 Robert.Ruxer@usoncology.com
El Paso Cancer Treatment Ctr-East, El Paso, Texas, 79915, United States; Recruiting
Juan Herrada, MD 915-599-1313 Juan.Herrada@usoncology.com
Texas Cancer Center - Denton, Denton, Texas, 76210, United States; Recruiting
Sharad K. Jain, MD 940-382-1022 Sharad.Jain@usoncology.com
Deke Slayton Cancer Center, Webster, Texas, 77598, United States; Recruiting
Suzanne McClure, MD 281-332-7505 Suzanne.McClure@usoncology.com
Waco Cancer Care and Research Center, Waco, Texas, 76712, United States; Recruiting
Robert L. Anderson, MD 254-399-0741 Robert.Anderson@usoncology.com
Tyler Cancer Center, Tyler, Texas, 75702, United States; Recruiting
Donald A. Richards, MD 903-579-9800 Donald.Richards@usoncology.com
Texas Cancer Center - Sherman, Sherman, Texas, 75090-0504, United States; Recruiting
Rudolf H. Good, MD 903-892-9455 Rudolf.Good@usoncology.com
San Antonio Tumor and Blood Clinic, Fredericksburg, Texas, 78624, United States; Recruiting
Jose A. Lopez, MD 830-990-0255 Jose.Lopez@usoncology.com
Hematology Oncology Associates of South Texas, San Antonio, Texas, 78229, United States; Recruiting
Gregory J. Guzley, MD 210-595-5324 Gregory.Guzley@usoncology.com
Paris Regional Cancer Center, Paris, Texas, 75460, United States; Recruiting
Sucharu Prakash, MD 903-785-0031 Sucharu.Prakash@usoncology.com
West Texas Cancer Center, Odessa, Texas, 79761, United States; Recruiting
Pankaj Khandelwal, MD 432-335-8275 Pankaj.Khandelwal@usoncology.com
Allison Cancer Center, Midland, Texas, 79701-5946, United States; Recruiting
David L. Watkins, MD 432-687-1949 David.Watkins@usoncology.com
Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc., Salem, Virginia, 24153, United States; Recruiting
Paul D. Richards, MD 540-774-8660 Paul.Richards@usoncology.com
Virginia Oncology Associates, Norfolk, Virginia, 23502, United States; Recruiting
Paul Conkling, MD 757-466-8683 Paul.Conkling@usoncology.com
Fairfax Northern Virginia Hematology Oncology, PC, Fairfax, Virginia, 22031, United States; Recruiting
Nicholas J. Robert, MD 703-391-5874 Nicholas.Robert@usoncology.com
Washington
Northwest Cancer Specialists, P.C., Vancouver, Washington, 98684, United States; Recruiting
David A. Smith, MD 360-944-9889 David.Smith@usoncology.com
Cancer Care Northwest, Spokane, Washington, 99218, United States; Recruiting
Stephen P. Anthony, MD 509-464-5100 Stephen.Anthony@usoncology.com
Puget Sound Cancer Centers, Seattle, Washington, 98133, United States; Recruiting
David E. Dong, MD 206-365-8252 David.Dong@usoncology.com
Puget Sound Cancer Centers, Edmonds, Washington, 98026, United States; Recruiting
Richard A. McGee, MD 425-775-1677 Richard.McGee@usoncology.com
More Information
Study ID Numbers: L_9210; 03-095
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: July 13, 2004
ClinicalTrials.gov Identifier: NCT00087802
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: July 13, 2004
ClinicalTrials.gov Identifier: NCT00087802
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Eloxatin (Drug Digest)
- Oxaliplatin Injection (Drug Digest)
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