S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
NCT ID: NCT00006487
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2000-10-31
2004-07-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
Detailed Description
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* Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer.
* Determine the toxicities of this treatment regimen in these patients.
* Determine the response rate in these patients treated with this regimen.
OUTLINE: Patients are assigned to one of two induction therapy arms.
* Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
* Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I.
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
Patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
cisplatin
During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
etoposide
During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion
During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion.
tirapazamine
During induction:
Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion
During consolidation:
330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
radiation therapy
Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
Interventions
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cisplatin
During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
etoposide
During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion
During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion.
tirapazamine
During induction:
Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion
During consolidation:
330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
radiation therapy
Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
* No malignant pericardial or pleural effusions, including any of the following:
* Cytologically positive effusions
* Exudative effusions not attributable to other etiologies
* No brain metastases
* Disease (measurable or non-measurable) must be present outside the area of prior surgical resection
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than ULN OR
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No symptomatic sensory neuropathy grade 1 or greater
* No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission
* No other medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for SCLC
Chemotherapy:
* No prior systemic chemotherapy for SCLC
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior thoracic radiotherapy for SCLC
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior thoracic or other major surgery and recovered
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Quynh-Thu X. Le, MD
Role: STUDY_CHAIR
Stanford University
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Cancer Center and Beckman Research Institute, City of Hope
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Stanford University
Stanford, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Oregon Cancer Center
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
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References
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Le QT, McCoy J, Williamson S, Ryu J, Gaspar LE, Edelman MJ, Dakhil SR, Sides SD, Crowley JJ, Gandara DR; Southwest oncology group. Phase I study of tirapazamine plus cisplatin/etoposide and concurrent thoracic radiotherapy in limited-stage small cell lung cancer (S0004): a Southwest Oncology Group study. Clin Cancer Res. 2004 Aug 15;10(16):5418-24. doi: 10.1158/1078-0432.CCR-04-0436.
Other Identifiers
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S0004
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068318
Identifier Type: -
Identifier Source: org_study_id