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A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer


OBJECTIVES:

I. 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.

II. Determine the time to treatment failure and response (confirmed and unconfirmed,
complete and partial) in patients with measurable disease treated with this regimen.

III. Determine the toxicity of this regimen in these patients. IV. 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.

Outcome Time Frame:

Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.

Safety Issue:

No

Principal Investigator

Quynh-Thu X. Le, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

NCI-2012-03042

NCT ID:

NCT00066742

Start Date:

September 2003

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
CCOP - Columbia River Oncology Program Portland, Oregon  97225
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Northwest Tacoma, Washington  98405-0986
Wesley Medical Center Wichita, Kansas  67214
City of Hope Comprehensive Cancer Center Duarte, California  91010
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Great Falls Clinic Great Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southwest Medical Center Liberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Veterans Affairs Medical Center - Hines Hines, Illinois  60141
Mount Carmel Health - West Hospital Columbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Salina Regional Health Center Salina, Kansas  67401
Stormont-Vail Cancer Center Topeka, Kansas  66604
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
Highland Hospital of Rochester Rochester, New York  14620
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
Mercy Medical Center Springfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington  98902
Washington Hematology-Oncology Specialists Yakima, Washington  98902
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Capital Medical Center Olympia, Washington  98502
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Auburn Regional Center for Cancer Care Auburn, Washington  98002
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Highlands Oncology Group - Springdale Springdale, Arkansas  72764
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Providence Centralia Hospital Regional Cancer Center Centralia, Washington  98531
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital Grass Valley, California  95945