Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066742

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: etoposide Drug: tirapazamine Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Tirapazamine Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Measurability of lesions [ Designated as safety issue: No ]
Objective response [ Designated as safety issue: No ]
Best response [ Designated as safety issue: No ]
Performance status [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	85
Study Start Date:	September 2003
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the overall survival of patients with limited stage small cell lung cancer treated with tirapazamine, cisplatin, and etoposide with concurrent thoracic radiotherapy followed by consolidation cisplatin and etoposide.
Determine the time to treatment failure and response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
Determine the toxicity of this regimen in these patients.
Correlate baseline PAI-1, VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Chemoradiotherapy: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; 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. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
Consolidation chemotherapy: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
- Diagnosis by sputum cytology is allowed provided there is pathologic confirmation of disease
- No positron-emission tomography scans for tumor staging
Measurable or non-measurable disease by CT scan, MRI, or x-ray
- Disease must be present outside the area of any prior surgical resection
No metastatic disease, including brain metastases
No malignant pericardial or pleural effusion*, defined as 1 of the following:
- Cytologically positive effusion
- Exudative effusion not attributable to other etiologies NOTE: *Patients with effusions too small to tap are eligible
Patients must be offered participation in SWOG-S9925

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 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

Renal

Creatinine clearance at least 50 mL/min* NOTE: *If calculated creatinine clearance is used, creatinine must be < 1.5 mg/dL

Other

Not pregnant or nursing
Fertile patients must use effective contraception
Patients with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms
No grade 1 or greater symptomatic sensory neuropathy
No other prior 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 that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic therapy for SCLC
No concurrent filgrastim (G-CSF) during radiotherapy administration

Chemotherapy

No prior chemotherapy for SCLC

Endocrine therapy

Not specified

Radiotherapy

No prior thoracic or neck radiotherapy
No concurrent intensity-modulated radiotherapy

Surgery

See Disease Characteristics
At least 2 weeks since prior thoracic or major surgery and recovered

Other

No concurrent amifostine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066742

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Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
Grass Valley, California, United States, 95945
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Colorado
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States, 81401
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Indiana
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Salina Regional Health Center
Salina, Kansas, United States, 67401
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135-2997
United States, Michigan
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic
Great Falls, Montana, United States, 59405
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New York
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
CCOP - Dayton
Dayton, Ohio, United States, 45429
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Medical Center
Springfield, Ohio, United States, 45504
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States, 79415-3364
United States, Washington
Allenmore Hospital
Tacoma, Washington, United States, 98405
Harborview Medical Center
Seattle, Washington, United States, 98104
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Capital Medical Center
Olympia, Washington, United States, 98507
CCOP - Northwest
Tacoma, Washington, United States, 98405
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Group Health Central Hospital
Seattle, Washington, United States, 98104-1387
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Providence Centralia Hospital Regional Cancer Center
Centralia, Washington, United States, 98531-9027
St. Clare Hospital
Tacoma, Washington, United States, 98499
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
St. Francis Hospital
Federal Way, Washington, United States, 98003
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405-3004
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Washington Hematology-Oncology Specialists
Yakima, Washington, United States, 98902
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Quynh-Thu X. Le, MD	Stanford University
Investigator:	Stephen K. Williamson, MD	University of Kansas
Investigator:	Primo N. Lara, MD	University of California, Davis
Investigator:	Zelanna Goldberg, MD	University of California, Davis

Study ID Numbers:	CDR0000318805, SWOG-S0222
Study First Received:	August 6, 2003
Last Updated:	April 18, 2009
ClinicalTrials.gov Identifier:	NCT00066742 History of Changes
Health Authority:	United States: Federal Government