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Home > "C" Clinical Trials Conditions > Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer



Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

For Condition: limited stage small cell lung cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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.
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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelKelley,  Study Chair,  Duke Comprehensive Cancer Center

Broward General Medical Center *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Luis  Barreras 954-771-0692

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Thomas  Shea 919-966-7746

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting Sreenivasa  Nattam 219-484-8830

Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Paul  Conkling 757-466-8683

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-464-8200

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Richard  Shadduck 412-578-4355

Baptist Hospital East - Louisville *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Alan  Venook 800-888-8664

Veterans Affairs Medical Center - Durham *Recruiting*
Durham,  North Carolina,  27705
United States
Recruiting Michael  Kelley 919-286-0411

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting George  Canellos 617-632-3470

Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville,  North Carolina,  28805
United States
Recruiting John  Lucke 828-299-2540

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Jeffrey  Crawford 919-684-5195

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Patricia  Cornett 415-221-4810 ext. 3423

Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting William  Patterson 573-882-6163

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Marc  Ernstoff 603-650-5534

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1009
United States
Recruiting Gerald  Clamon 319-356-1932

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

Palm Beach Cancer Institute *Recruiting*
West Palm Beach,  Florida,  33401
United States
Recruiting Robert  Jacobson 561-366-4150

UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-7680
United States
Recruiting Margaret  Kessinger 402-559-7511

Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting Chitha  Hulugalle 702-696-3000

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

Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Martin  Edelman 410-328-2703

Cape Fear Valley Health System *Recruiting*
Fayetteville,  North Carolina,  28302-2000
United States
Recruiting Kamal  Bakri 910-609-6910

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

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

Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke,  Virginia,  24014
United States
Recruiting Paul  Richards 540-982-0237

Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction,  Vermont,  05009
United States
Recruiting Joseph  O'Donnell 802-295-9363 ext. 5480

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting David  Hurd 336-716-2088

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-982-4963

Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood,  Florida,  33021
United States
Recruiting Atif  Hussein 954-986-6363

Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75216
United States
Recruiting Barry  Levinson 214-648-4193

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

Northeast Alabama Regional Medical Center *Recruiting*
Anniston,  Alabama,  36207
United States
Recruiting Thomas  Twele 256-236-2549

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla,  California,  92093-0658
United States
Recruiting Stephen  Seagren 858-657-7020

Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego,  California,  92161
United States
Recruiting Saeeda  Kirmani 619-552-8585 ext. 3356

Martha Jefferson Hospital *Recruiting*
Charlottesville,  Virginia,  22902
United States
Recruiting Stefan  Gorsch 434-982-8410

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Clifford  Hudis 212-639-6483

Saint Anthony Medical Center *Recruiting*
Rockford,  Illinois,  61108
United States
Recruiting Richard  Nora 815-227-2273

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Keith  Shulman 773-564-5022

Mount Sinai Medical Center, NY *Recruiting*
New York City,  New York,  10029
United States
Recruiting Lewis  Silverman 212-241-5520

St. Mary's Medical Center *Recruiting*
Huntington,  West Virginia,  25701
United States
Recruiting Gerrit  Kimmey 304-528-4645

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Edward  Gelmann 202-444-7303

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Pankaj  Bhargava 508-856-6884

Vermont Cancer Center at University of Vermont *Recruiting*
Burlington,  Vermont,  05401-3498
United States
Recruiting Hyman  Muss 802-847-3827

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

CCOP - North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Vincent  Vinciguerra 516-562-8915

West Suburban Center for Cancer Care *Recruiting*
River Forest,  Illinois,  60305
United States
Recruiting John  Showel 708-763-2700

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5000
United States
Recruiting Joseph  Drabick 202-782-6751

Florida Hospital Cancer Institute *Recruiting*
Orlando,  Florida,  32804
United States
Recruiting Jane  Crofton 407-303-2090

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Alan  Lefor 310-423-5874

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Rafat  Ansari 574-284-7977

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390
United States
Recruiting Debasish  Tripathy 214-648-5113

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103
United States
Recruiting Edison  Catalano 856-342-2506

Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55417
United States
Recruiting Vicki  Morrison 612-725-2000 ext. 4135

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Clara  Bloomfield 614-293-7518

New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Scott  Wadler 212-746-2844

Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Steven  Krasnow 202-745-8178

Lifespan: The Miriam Hospital *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting William  Sikov 401-793-7151

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse,  New York,  13217
United States
Recruiting Jeffrey  Kirshner 315-472-7504

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

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Michael  Perry 573-882-4979

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Bruce  Peterson 612-624-5631

Missouri Baptist Cancer Center *Recruiting*
St. Louis,  Missouri,  63131
United States
Recruiting Alan  Lyss 314-996-5514

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Daniel  Budman 516-562-8958

Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica,  New York,  11432
United States
Recruiting Hans  Grunwald 718-883-4118

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Karen  Wendling 773-834-7424

NorthEast Oncology Associates *Recruiting*
Concord,  North Carolina,  28025
United States
Recruiting James  Wall 704-783-1370

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

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Rogerio  Lilenbaum 305-674-2625

Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo,  New York,  14215
United States
Recruiting Lynn  Steinbrenner 716-862-3191

Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-476-7461

CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting John  Ellerton 702-384-0013

New Hanover Regional Medical Center *Recruiting*
Wilmington,  North Carolina,  28402-9025
United States
Recruiting Cyrus  Kotwall 910-763-4630

FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst,  North Carolina,  28374
United States
Recruiting Ellen  Willard 910-295-9205

New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett,  New Hampshire,  03106
United States
Recruiting Douglas  Weckstein 603-622-6484

Barnes-Jewish Hospital *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Nancy  Bartlett 314-747-3000


Additional Information:
Study ID Numbers:
  CDR0000339871;  CALGB-30206
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072527

Other Limited Stage Small Cell Lung Cancer Studies:
1. Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

3. Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer

4. Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

5. Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer

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