Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy
NCT ID: NCT00375193
Last Updated: 2019-10-24
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
75 participants
INTERVENTIONAL
2006-11-01
2009-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial.
Amrubicin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
Interventions
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Amrubicin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Richard S Ungerleider, MD
Role: STUDY_DIRECTOR
Theradex
Locations
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Hematology Oncology Associates
Phoenix, Arizona, 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
Indianapolis, Indiana, United States
Norton Healthcare - Louisville Oncology
Louisville, Kentucky, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, United States
Alliance Hematology Oncology, PA - Carroll County Cancer Center
Westminster, Maryland, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Minnesota Onc/Hem, PA - Minneapolis
Minneapolis, Minnesota, United States
University of MN/Division of Hematology, Oncology & Transplantation
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
Arch Medical Group - Arch Medical Services, Inc.
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 Center
Syracuse, New York, United States
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, United States
Sarah Cannon
Nashville, Tennessee, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology, PA - Bedford
Bedford, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, P.A. - Dallas
Dallas, Texas, United States
Texas Oncology, P.A., Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology, PA - Fort Worth
Fort Worth, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, United States
Texas Oncology, PA - Deke Slayton Cancer Center
Webster, Texas, United States
Texas Oncology - Wichita Falls
Wichita Falls, Texas, United States
Virginia Oncology Associates - Norfolk, VA
Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States
Puget Sound Cancer Center
Seattle, Washington, United States
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States
Yakima Regional Cancer Care Center - North Star Lodge Cancer Center
Yakima, Washington, United States
Free University Medical Center
Amsterdam, , Netherlands
Royal Marsden Hospital in Downs Road
Sutton, Surrey, United Kingdom
Countries
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References
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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)
Other Identifiers
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CNF3140-SCLC-002
Identifier Type: -
Identifier Source: org_study_id
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