Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.
NCT ID: NCT00319969
Last Updated: 2009-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2006-04-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Amrubicin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
2
Topotecan 1.5mg/m\<2\> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Topotecan
Topotecan 1.5mg/m\<2\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Interventions
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Amrubicin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Topotecan
Topotecan 1.5mg/m\<2\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Extensive disease (ED) at time of study entry
* Response to first-line platinum-based chemotherapy
* Recurrent or progressive SCLC ≥90 days after completion of first-line therapy
* At least 18 years of age
* ECOG Performance Status of 0, 1, or 2
* Measurable disease defined by RECIST criteria
* Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
* Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.
CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the leions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (eg., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
* Adequate organ function including the following:
* Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9 g/dL
* Hepatic: bilirubin ≤1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 X ULN
* Renal: serum creatinine \<2.0mg/dL or calculated creatinine clearance \>60mL/min
* Cardiac: Left ventricular ejection fraction (LVEF) ≥50%
* Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods during the study.
* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Exclusion Criteria
* Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to \<25% of the bone marrow.
* More than 1 prior chemotherapy regimen for SCLC
* Prior anthracycline treatment
* Participation in any investigational drug study within 28 days prior to study entry
* Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence; prior low grade \[Gleason score ≤6\] localized prostate cancer is allowed)
* Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
* Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week.
* History of interstitial lung disease or pulmonary fibrosis
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Responsible Party
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Pharmion Corporation
Principal Investigators
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Richard S Ungerleider, MD
Role: STUDY_DIRECTOR
Theradex
Locations
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Birmingham Hematology & Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Alta Bates Medical Center - Comprehensive Cancer Center
Berkeley, California, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States
Rocky Mountain Cancer Center - Sky Ridge
Lone Tree, Colorado, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, PA
Ocoee, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Cancer Care & Hematology Specialists of Chicago
Niles, Illinois, United States
Oncology & Hematology of Central Illinois
Peoria, Illinois, United States
Blessing Cancer Center
Quincy, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Hope Center
Terre Haute, Indiana, United States
Norton Healthcare - Louisville Oncology
Louisville, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building
Baltimore, Maryland, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, United States
Alliance Hematology Oncology, PA - Carroll County Cancer Center
Westminster, Maryland, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
Hematology/Oncology Consultants
St Louis, Missouri, United States
Arch Medical Services - Center for Cancer Care & Research
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology, PC
Albany, New York, United States
SUNY Upstate Medical University - Regional Oncology Center
Syracuse, New York, United States
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Oncology - Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology, PA
Fort Worth, Texas, United States
Alison Cancer Center
Midland, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care & Research Center
Waco, Texas, United States
Texas Oncology, PA - Deke Slayton Cancer Center
Webster, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology & Hematology Associates of SW Virginia, Inc.
Salem, Virginia, United States
Puget Sound Cancer Center
Seattle, Washington, United States
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States
Countries
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Other Identifiers
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CNF3140-SCLC-05004
Identifier Type: -
Identifier Source: org_study_id