Not Signed In -
Carboplatin |
Paraplatin |
Clinical Trial: Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| limited stage small cell lung cancer | Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: irinotecan Procedure: chemotherapy Procedure: radiation therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Cisplatin and Irinotecan Followed By Carboplatin, Etoposide, and Radiotherapy in Patients With Limited Stage Small Cell Lung Cancer
Further Study Details:
OBJECTIVES: Primary
- Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide, and radiotherapy, in terms of 2-year survival, in patients with limited stage small cell lung cancer.
Secondary
- Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen.
- Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- Consolidation therapy: Immediately after the completion of induction therapy, patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks. After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Limited stage disease, defined as the following:
- Disease restricted to 1 hemithorax with regional lymph node metastases, including hilar, ipsilateral, or contralateral mediastinal lymph nodes
- No clinically suspected or confirmed supraclavicular lymph node metastases
- No pathologically enlarged contralateral hilar lymph nodes
- No pleural effusions that are visible on plain chest radiographs, whether they are cytologically positive or negative
- Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Pleural/pericardial effusions are not considered measurable
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No "currently active" second malignancy except nonmelanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No prior chemotherapy for SCLC
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy except the following:
- Steroids for adrenal failure
- Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
- Intermittent dexamethasone as an antiemetic or adjunct to prophylactic cranial radiotherapy
Radiotherapy
- See Endocrine therapy
- No prior radiotherapy for SCLC
- No concurrent intensity-modulated radiotherapy
Surgery
- Not specified
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Steven H. Krasnow, MD 202-745-8178 krasnow.steven@washington.va.gov
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363 ahussein@mhs.net
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C) 561-366-4150
Illinois
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Thomas E. Lad, MD 312-996-2046
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Vicki A. Morrison, MD 612-467-4135 morri002@tc.umn.edu
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
William P. Patterson, MD 573-882-6163
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
Chitha R. Hulugalle, MD 702-696-3000
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Douglas Jay Weckstein, MD 603-622-6484 d.weckstein@nhoh.com
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Edison Catalano, MD 856-342-2506
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Vincent P. Vinciguerra, MD 516-562-8954
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 212-639-6483
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Scott Wadler, MD 212-746-2844 scw2004@med.cornell.edu
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Daniel R. Budman, MD 516-562-8958
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Ellis G. Levine, MD 716-845-8547
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Lynn Marie Steinbrenner, MD 716-862-3191 lynn.steinbrenner@med.va.gov
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
Leslie Marion Howard, MD 315-476-7461 ext. 4018 leslie.howard@med.va.gov
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
Kamal M. Bakri, MD 910-609-6910
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Ellen M. Willard, MD 910-295-9205
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621 crawf006@mc.duke.edu
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
Thomas C. Shea, MD 919-966-7746 sheaT@med.unc.edu
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
John C. Lucke, MD 828-299-2540
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Michael J. Kelley, MD 919-286-0411 ext. 7326
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Cyrus A. Kotwall, MD 910-763-4630
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Clara D. Bloomfield, MD 614-293-7518 bloomfield-1@medctr.osu.edu
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Howard Ozer, MD, PhD 405-271-4022
Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting
Richard K. Shadduck, MD 412-578-4355 rshadduck@msn.com
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
William M. Sikov, MD 401-793-7151 wsikov@lifespan.org
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Hyman Bernard Muss, MD 802-847-3827
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
Stefan M. Gorsch, MD 434-982-8410
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Paul R. Conkling, MD 757-466-8683
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Study chairs or principal investigators
Michael J. Kelley, MD, Study Chair, Duke Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000339871; CALGB-30206; NCT00072527
Record last reviewed: August 2004
Last Updated: April 5, 2005
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072527
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: August 2004
Last Updated: April 5, 2005
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072527
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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