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Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)


- Determine the survival of patients with extensive stage small cell lung cancer treated
with gemcitabine and irinotecan.

- Determine the response rates (confirmed and unconfirmed, complete and partial) of
patients treated with this regimen.

- Determine the overall toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on
days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.

Inclusion Criteria


- Histologically or cytologically confirmed extensive stage small cell lung cancer

- Malignant pleural effusion constitutes extensive stage disease

- Must have disease outside area of prior surgical resection or a new lesion must be

- Controlled brain metastases allowed (asymptomatic and previously treated with surgery
and/or radiotherapy)

- Brain metastases must be re-evaluated by CT scan or MRI after completion of
radiotherapy or surgery



- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN


- Not specified


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately
treated stage I or II cancer in complete remission


Biologic therapy:

- No prior biologic therapy for SCLC


- No prior systemic chemotherapy for SCLC

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy for SCLC except for brain metastases


- See Disease Characteristics

- At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered

Type of Study:


Study Design:

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

Principal Investigator

Wallace L. Akerley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

November 2008

Related Keywords:

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



Baylor College of MedicineHouston, Texas  77030
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University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
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University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
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CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
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Huntsman Cancer InstituteSalt Lake City, Utah  84112
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St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
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CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
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Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
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University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
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Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
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Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
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Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
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Boston Medical CenterBoston, Massachusetts  02118
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CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
OHSU Cancer InstitutePortland, Oregon  97239
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
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Madigan Army Medical CenterTacoma, Washington  98431-5048
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CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
City of Hope Comprehensive Cancer CenterDuarte, California  91010
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Barrett Cancer CenterCincinnati, Ohio  45267-0502
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060
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