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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 CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - NorthwestTacoma, Washington  98405-0986
Wesley Medical CenterWichita, Kansas  67214
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Salina Regional Health CenterSalina, Kansas  67401
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
Mercy Medical CenterSpringfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Washington Hematology-Oncology SpecialistsYakima, Washington  98902
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Salem Hospital Regional Cancer Care ServicesSalem, Oregon  97309-5014
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Auburn Regional Center for Cancer CareAuburn, Washington  98002
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
Providence Centralia Hospital Regional Cancer CenterCentralia, Washington  98531
Sierra Nevada Cancer Center at Sierra Nevada Memorial HospitalGrass Valley, California  95945