- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375193
Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy
October 16, 2019 updated by: Celgene
A Phase 2 Trial of Single-Agent Amrubicin in Patients With Extensive Disease Small Cell Lung Cancer That is Refractory or Progressive Within 90 Days of Completion of First Line Platinum-based Chemotherapy
The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease.
Study Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands, NL 1081 HV
- Free University Medical Center
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Surrey
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Sutton, Surrey, United Kingdom
- Royal Marsden Hospital in Downs Road
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Arizona
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Phoenix, Arizona, United States, 85012
- Hematology Oncology Associates
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Colorado
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Center - Sky Ridge
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Florida
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Ocala, Florida, United States, 34474
- Ocala Oncology Center
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Ocoee, Florida, United States, 34761
- Cancer Centers of Florida, PA
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Georgia
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Columbus, Georgia, United States, 31904
- John B. Amos Cancer Center
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Illinois
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Niles, Illinois, United States, 60714
- Cancer Care & Hematology Specialists of Chicago
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Peoria, Illinois, United States, 61602
- Oncology & Hematology of Central Illinois
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Quincy, Illinois, United States, 62301
- Blessing Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46227
- Central Indiana Cancer Centers - Indianapolis
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Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Healthcare - Louisville Oncology
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Maryland
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Columbia, Maryland, United States, 21044
- Maryland Oncology Hematology, PA
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Westminster, Maryland, United States, 21157
- Alliance Hematology Oncology, PA - Carroll County Cancer Center
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Michigan
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota Onc/Hem, PA - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of MN/Division of Hematology, Oncology & Transplantation
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Missouri
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Columbia, Missouri, United States, 65201
- Missouri Cancer Associates
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Saint Joseph, Missouri, United States, 64507
- St. Joseph Oncology, Inc.
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Saint Louis, Missouri, United States, 63141
- Arch Medical Group - Arch Medical Services, Inc.
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Nevada
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Las Vegas, Nevada, United States, 89109
- Comprehensive Cancer Centers of Nevada
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New York
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Albany, New York, United States, 12208
- New York Oncology Hematology, PC
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical Center
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North Carolina
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Hickory, North Carolina, United States, 28602
- Northwestern Carolina Oncology & Hematology
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Raleigh, North Carolina, United States, 27607
- Raleigh Hematology Oncology Associates
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Oregon
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Eugene, Oregon, United States, 97401
- Willamette Valley Cancer Center
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Pennsylvania
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Kingston, Pennsylvania, United States, 18704
- Medical Oncology Associates
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Tennessee
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center, Knoxville
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Nashville, Tennessee, United States, 37203
- Sarah Cannon
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Texas
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Amarillo, Texas, United States, 79106
- Texas Oncology - Amarillo
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Beaumont, Texas, United States, 77702-1449
- Mamie McFaddin Ward Cancer Center
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Bedford, Texas, United States, 76022
- Texas Oncology, PA - Bedford
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Dallas, Texas, United States, 75230-2510
- Texas Cancer Center at Medical City
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Dallas, Texas, United States, 75246
- Texas Oncology, P.A. - Dallas
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Dallas, Texas, United States, 75246
- Texas Oncology, P.A., Sammons Cancer Center
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Fort Worth, Texas, United States, 76104
- Texas Oncology, PA - Fort Worth
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Odessa, Texas, United States, 79761
- West Texas Cancer Center
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Tyler, Texas, United States, 75702
- Tyler Cancer Center
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Waco, Texas, United States, 76712
- Texas Oncology Cancer Care and Research Center
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Webster, Texas, United States, 77598
- Texas Oncology, PA - Deke Slayton Cancer Center
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Wichita Falls, Texas, United States, 76310
- Texas Oncology - Wichita Falls
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates - Norfolk, VA
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Salem, Virginia, United States, 24153
- Oncology & Hematology Associates Of Southwest Virginia, Inc.
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Washington
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Seattle, Washington, United States, 98133
- Puget Sound Cancer Center
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Vancouver, Washington, United States, 98684
- Northwest Cancer Specialists - Vancouver Cancer Center
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Yakima, Washington, United States, 98902
- Yakima Regional Cancer Care Center - North Star Lodge Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histological or cytological diagnosis of SCLC; extensive-disease (ED) at time of study entry
Refractory to first-line platinum-based chemotherapy (i.e., has received one prior platinum-based chemotherapy regimen) defined as one of the following:
- Best response to first-line chemotherapy is radiographically documented progression (refractory disease)
- Best response to first-line chemotherapy is radiographically documented response or stable disease, with subsequent documented progression during continuing chemotherapy (resistant relapse)
- Documented progression within 90 days of completion of first-line chemotherapy (last dose of chemotherapy), regardless of best response to treatment (resistant relapse)
- 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 lesions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (e.g., 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 ≥9g/dL.
- Hepatic: bilirubin ≤ 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 X ULN.
- Renal: serum creatinine < 2.0 mg/dL or calculated creatinine clearance >60 mL/min.
- Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study).
- Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-bearing 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 regiment for SCLC
- Prior anthracycline treatment
- Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effecxts of prior therapies, excluding alopecia
- Patients with secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 2 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
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Experimental: 1
Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial.
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Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Objective tumor response rate according to RECIST
Time Frame: Until Disease Progression
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Until Disease Progression
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Duration of overall response
Time Frame: Until Disease Progression
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Until Disease Progression
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Time to tumor progression
Time Frame: Until Disease Progression
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Until Disease Progression
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Progression free survival
Time Frame: Until death or disease progression
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Until death or disease progression
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Overall survival
Time Frame: Until death
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Until death
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Toxicity profile
Time Frame: Until 30 days after final dose
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Until 30 days after final dose
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Incidence of cardiomyopathy
Time Frame: Until end of study participation
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Until end of study participation
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Incidence of CNS progression
Time Frame: Until disease progression
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Until disease progression
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Pharmacokinetic parameters
Time Frame: Cycle 1 only
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Cycle 1 only
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Richard S Ungerleider, MD, Theradex
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Alemany C, Conkling P, Spigel DR, Dudek AZ, Shah C, Salgia R, McNally R, Renschler MF, Oliver JW. Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. J Clin Oncol. 2010 May 20;28(15):2598-603. doi: 10.1200/JCO.2009.26.7682. Epub 2010 Apr 12.
- Spigel DR, et al. Amrubicin (AMR) and cardiotoxicity in second-line treatment of small cell lung cancer (SCLC): A pooled analysis of left ventricular ejection fraction (LVEF) in two phase II trials. 2009 ASCO Annual Meeting, May 29-June 2, 2009, Chicago, IL. Abstract No.e19019. J Clin Oncol 2009;27(suppl)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 9, 2006
First Submitted That Met QC Criteria
September 9, 2006
First Posted (Estimate)
September 12, 2006
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNF3140-SCLC-002
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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