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Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with
recurrent or refractory small cell lung cancer when treated with gemcitabine plus
irinotecan. II. Determine the overall and failure free survival of these patients when
treated with this regimen. III. Determine the duration of response of these patients after
this treatment. IV. Evaluate the toxicity associated with the administration of this
treatment in this patient population.

OUTLINE: Patients are stratified according to prior response duration (progression 90 days
or more after initial therapy vs progression less than 90 days after initial therapy or no
response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan
IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of
disease progression or unacceptable toxicity. Patients are followed every 3 months for 1
year, then every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory
small cell lung cancer Measurable disease At least 20 mm with conventional techniques OR
At least 10 mm with spiral CT scan The following are not considered measurable: Bone
lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not
confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a
previously irradiated area Known CNS metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than
2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception
No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in
situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy or chemoradiotherapy regimen No prior gemcitabine or irinotecan
Endocrine therapy: Not specified Radiotherapy: No more than 1 prior chemoradiotherapy
regimen At least 2 weeks since prior cranial radiotherapy for CNS metastases No concurrent
cranial radiotherapy Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

February 2008

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722