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Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

This study has been completed.
Information provided by:
Celgene Identifier:
First received: April 27, 2006
Last updated: September 28, 2009
Last verified: September 2009
The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive.

Condition Intervention Phase
Small Cell Lung Cancer
Drug: Amrubicin
Drug: Topotecan
Phase 2

Celgene Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • Objective tumor response rate [ Time Frame: Until Disease Progression ]

Secondary Outcome Measures:
  • Time to tumor progression [ Time Frame: Until Disease Progression ]
  • Progression free survival [ Time Frame: Until death or disease progression ]
  • Overall survival (median survival time; 1 year survival) [ Time Frame: Until death ]
  • Toxicity profile [ Time Frame: Until 30 days after final dose ]
  • Incidence of cumulative cardiomyopathy [ Time Frame: Until end of study participation ]
  • Regression of CNS metastases [ Time Frame: Until disease progression ]

Enrollment: 76
Study Start Date: April 2006
Study Completion Date: January 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Drug: Amrubicin
Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Active Comparator: 2
Topotecan 1.5mg/m<2> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Drug: Topotecan
Topotecan 1.5mg/m<2> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Other Name: Hycamtin(R)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological diagnosis of SCLC
  • 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:

  • Pregnant or nursing women
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00319969

  Hide Study Locations
United States, Alabama
Birmingham Hematology & Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, California
Alta Bates Medical Center - Comprehensive Cancer Center
Berkeley, California, United States, 94704
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
United States, Colorado
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Center - Sky Ridge
Lone Tree, Colorado, United States, 80124
United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, PA
Ocoee, Florida, United States, 34761
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Cancer Care & Hematology Specialists of Chicago
Niles, Illinois, United States, 60714
Oncology & Hematology of Central Illinois
Peoria, Illinois, United States, 61602
Blessing Cancer Center
Quincy, Illinois, United States, 62301
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Kentucky
Norton Healthcare - Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building
Baltimore, Maryland, United States, 21231
Maryland Oncology Hematology, PA
Columbia, Maryland, United States, 21044
Alliance Hematology Oncology, PA - Carroll County Cancer Center
Westminster, Maryland, United States, 21157
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Arch Medical Services - Center for Cancer Care & Research
St Louis, Missouri, United States, 63141
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
Hematology/Oncology Consultants
St. Louis, Missouri, United States, 63136
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New York
New York Oncology Hematology, PC
Albany, New York, United States, 12208
SUNY Upstate Medical University - Regional Oncology Center
Syracuse, New York, United States, 13210
United States, North Carolina
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, United States, 28602
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Northwest Cancer Specialists
Portland, Oregon, United States, 97225
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230-2510
Texas Oncology, PA
Dallas, Texas, United States, 75231
Texas Oncology - Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology, PA
Fort Worth, Texas, United States, 76104
Alison Cancer Center
Midland, Texas, United States, 79701
West Texas Cancer Center
Odessa, Texas, United States, 79761
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care & Research Center
Waco, Texas, United States, 76712
Texas Oncology, PA - Deke Slayton Cancer Center
Webster, Texas, United States, 77598
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates of SW Virginia, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Cancer Center
Seattle, Washington, United States, 98133
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Celgene Corporation
Study Director: Richard S Ungerleider, MD Theradex
  More Information

Responsible Party: Kathy Knapp, Clinical Program Manager, Pharmion Corporation Identifier: NCT00319969     History of Changes
Other Study ID Numbers: CNF3140-SCLC-05004
Study First Received: April 27, 2006
Last Updated: September 28, 2009

Keywords provided by Celgene:
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on March 27, 2017