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

NCT00319969 | Completed Phase 2

• 1 other identifier: CNF3140-SCLC-05004
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 47

Brief Summary

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; amrubicin

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate

  Until Disease Progression

Secondary Outcomes (6)

• Time to tumor progression

  Until Disease Progression

• Progression free survival

  Until death or disease progression

• Overall survival (median survival time; 1 year survival)

  Until death

• Toxicity profile

  Until 30 days after final dose

• Incidence of cumulative cardiomyopathy

  Until end of study participation

Study Arms (2)

1

EXPERIMENTAL

Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.

Drug: Amrubicin

2

ACTIVE COMPARATOR

Topotecan 1.5mg/m\<2\> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.

Drug: Topotecan

Interventions

Amrubicin DRUG

Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.

1

Topotecan DRUG

Topotecan 1.5mg/m\<2\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.

Also known as: Hycamtin(R)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%

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

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (47)

Birmingham Hematology & Oncology

Birmingham, Alabama, 35205, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Alta Bates Medical Center - Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Rocky Mountain Cancer Center - Denver

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Center - Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Centers of Florida, PA

Ocoee, Florida, 34761, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Cancer Care & Hematology Specialists of Chicago

Niles, Illinois, 60714, United States

Location

Oncology & Hematology of Central Illinois

Peoria, Illinois, 61602, United States

Location

Blessing Cancer Center

Quincy, Illinois, 62301, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Norton Healthcare - Louisville Oncology

Louisville, Kentucky, 40202, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building

Baltimore, Maryland, 21231, United States

Location

Maryland Oncology Hematology, PA

Columbia, Maryland, 21044, United States

Location

Alliance Hematology Oncology, PA - Carroll County Cancer Center

Westminster, Maryland, 21157, United States

Location

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Hematology/Oncology Consultants

St Louis, Missouri, 63136, United States

Location

Arch Medical Services - Center for Cancer Care & Research

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12208, United States

Location

SUNY Upstate Medical University - Regional Oncology Center

Syracuse, New York, 13210, United States

Location

Northwestern Carolina Oncology & Hematology

Hickory, North Carolina, 28602, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Northwest Cancer Specialists

Portland, Oregon, 97225, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230-2510, United States

Location

Texas Oncology, PA

Dallas, Texas, 75231, United States

Location

Texas Oncology - Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology, PA

Fort Worth, Texas, 76104, United States

Location

Alison Cancer Center

Midland, Texas, 79701, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer Care & Research Center

Waco, Texas, 76712, United States

Location

Texas Oncology, PA - Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology & Hematology Associates of SW Virginia, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center

Seattle, Washington, 98133, United States

Location

Northwest Cancer Specialists - Vancouver Cancer Center

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amrubicin; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Richard S Ungerleider, MD

  Theradex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: January 1, 2009
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

US (47)