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Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer


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

Thank you

Trial Information

Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer


OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated
extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and
filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these
patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1
hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive
filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood
counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each
subsequent course of chemotherapy. Treatment repeats every 3 weeks for 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 over 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven, previously untreated
extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR
Previously treated with radiotherapy and/or surgery Measurable or evaluable disease
outside the area of prior surgical resection or a new lesion must be present

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least
3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25
times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal:
Creatinine no greater than ULN Creatinine clearance at least 50 mL/min Other: 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 any stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC
Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See
Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and
recovered

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Frank Dunphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067367

NCT ID:

NCT00004137

Start Date:

October 1999

Completion Date:

November 2008

Related Keywords:

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

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
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
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
St. Elizabeth's Medical Center Boston, Massachusetts  02135-2997
Oregon Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098