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

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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Amrubicin; Drug: Topotecan

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Hycamtin(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective tumor response rate	Until Disease Progression

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celgene Corporation
• Investigators: Study Director: Richard S Ungerleider, MD, Theradex

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 27, 2006
• First Submitted That Met QC Criteria: April 27, 2006
• First Posted (Estimate): April 27, 2006

Study Record Updates

• Last Update Posted (Estimate): September 30, 2009
• Last Update Submitted That Met QC Criteria: September 28, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: small cell lung cancer; amrubicin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Topotecan; Amrubicin
• Other Study ID Numbers: CNF3140-SCLC-05004