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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319969
• Other study ID #: CNF3140-SCLC-05004
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: September 28, 2009
• Start date: April 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Amrubicin
Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
• Topotecan
Topotecan 1.5mg/m<2> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.

Locations

Country	Name	City	State
United States	New York Oncology Hematology, PC	Albany	New York
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Alta Bates Medical Center - Comprehensive Cancer Center	Berkeley	California
United States	Birmingham Hematology & Oncology	Birmingham	Alabama
United States	Maryland Oncology Hematology, PA	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Oncology - Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	Rocky Mountain Cancer Center - Denver	Denver	Colorado
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Texas Oncology, PA	Fort Worth	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Northwestern Carolina Oncology & Hematology	Hickory	North Carolina
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Rocky Mountain Cancer Center - Sky Ridge	Lone Tree	Colorado
United States	Norton Healthcare - Louisville Oncology	Louisville	Kentucky
United States	Alison Cancer Center	Midland	Texas
United States	Minnesota Oncology Hematology, PA	Minneapolis	Minnesota
United States	Cancer Care & Hematology Specialists of Chicago	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, PA	Ocoee	Florida
United States	West Texas Cancer Center	Odessa	Texas
United States	Oncology & Hematology of Central Illinois	Peoria	Illinois
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	Northwest Cancer Specialists	Portland	Oregon
United States	Blessing Cancer Center	Quincy	Illinois
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Oncology & Hematology Associates of SW Virginia, Inc.	Salem	Virginia
United States	Puget Sound Cancer Center	Seattle	Washington
United States	Arch Medical Services - Center for Cancer Care & Research	St Louis	Missouri
United States	St. Joseph Oncology, Inc.	St. Joseph	Missouri
United States	Hematology/Oncology Consultants	St. Louis	Missouri
United States	SUNY Upstate Medical University - Regional Oncology Center	Syracuse	New York
United States	Hope Center	Terre Haute	Indiana
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists - Vancouver Cancer Center	Vancouver	Washington
United States	Texas Oncology Cancer Care & Research Center	Waco	Texas
United States	Texas Oncology, PA - Deke Slayton Cancer Center	Webster	Texas
United States	Alliance Hematology Oncology, PA - Carroll County Cancer Center	Westminster	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate		Until Disease Progression	No
Secondary	Time to tumor progression		Until Disease Progression	No
Secondary	Progression free survival		Until death or disease progression	No
Secondary	Overall survival (median survival time; 1 year survival)		Until death	No
Secondary	Toxicity profile		Until 30 days after final dose	Yes
Secondary	Incidence of cumulative cardiomyopathy		Until end of study participation	Yes
Secondary	Regression of CNS metastases		Until disease progression	No