Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00319969
First received: April 27, 2006
Last updated: September 28, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Amrubicin
Drug: Topotecan
Phase 2

Celgene Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Objective tumor response rate [ Time Frame: Until Disease Progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression [ Time Frame: Until Disease Progression ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Until death or disease progression ] [ Designated as safety issue: No ]
  • Overall survival (median survival time; 1 year survival) [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Until 30 days after final dose ] [ Designated as safety issue: Yes ]
  • Incidence of cumulative cardiomyopathy [ Time Frame: Until end of study participation ] [ Designated as safety issue: Yes ]
  • Regression of CNS metastases [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: April 2006
Study Completion Date: January 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hycamtin(R)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319969

  Show 47 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Richard S Ungerleider, MD Theradex
  More Information

No publications provided

Responsible Party: Kathy Knapp, Clinical Program Manager, Pharmion Corporation
ClinicalTrials.gov Identifier: NCT00319969     History of Changes
Other Study ID Numbers: CNF3140-SCLC-05004
Study First Received: April 27, 2006
Last Updated: September 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
small cell lung cancer
amrubicin

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Amrubicin
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014