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

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00319969

Run by

Celgene Corporation

People needed

76

Starts

2006-04-01

Expected to finish

2009-01-01

Last updated by the study team

2009-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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