- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005972
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Bettendorf, Iowa, United States, 52722
- Hematology Oncology Associates of the Quad Cities
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, United States, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, United States, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Bennington, Vermont, United States, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, United States, 23249
- Veterans Affairs Medical Center - Richmond
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gemcitabine + irinotecan
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: Up to 18 weeks
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Up to 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: Up to 18 weeks
|
Up to 18 weeks
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failure-free survival
Time Frame: Up to 18 weeks
|
Up to 18 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Caio Max Rocha Lima, MD, Medical University of South Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Gemcitabine
- Irinotecan
Other Study ID Numbers
- CALGB-39902
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000067959 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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