Clinical trial NCT00319969: Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
amrubicin
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective tumor response rate
timeFrame: Until Disease Progression
Secondary outcomes:
measure: Time to tumor progression
timeFrame: Until Disease Progression
measure: Progression free survival
timeFrame: Until death or disease progression
measure: Overall survival (median survival time; 1 year survival)
timeFrame: Until death
measure: Toxicity profile
timeFrame: Until 30 days after final dose
measure: Incidence of cumulative cardiomyopathy
timeFrame: Until end of study participation
measure: Regression of CNS metastases
timeFrame: Until disease progression
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology & Oncology
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Medical Center - Comprehensive Cancer Center
state: California
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Denver
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Center - Sky Ridge
state: Colorado
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, PA
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicago
state: Illinois
city: Peoria
country: United States
facility: Oncology & Hematology of Central Illinois
state: Illinois
city: Quincy
country: United States
facility: Blessing Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare - Louisville Oncology
state: Kentucky
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Westminster
country: United States
facility: Alliance Hematology Oncology, PA - Carroll County Cancer Center
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: St Louis
country: United States
facility: Arch Medical Services - Center for Cancer Care & Research
state: Missouri
city: St. Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Hematology/Oncology Consultants
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Regional Oncology Center
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Oncology & Hematology
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, PA
state: Texas
city: Midland
country: United States
facility: Alison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care & Research Center
state: Texas
city: Webster
country: United States
facility: Texas Oncology, PA - Deke Slayton Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of SW Virginia, Inc.
state: Virginia
city: Seattle
country: United States
facility: Puget Sound Cancer Center
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver Cancer Center
state: Washington
Study officials:
affiliation: Theradex
name: Richard S Ungerleider, MD
role: STUDY_DIRECTOR
References: