AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00547651
First received: October 18, 2007
Last updated: March 26, 2013
Last verified: March 2013

October 18, 2007
March 26, 2013
September 2007
May 2011   (final data collection date for primary outcome measure)
The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy. [ Time Frame: Until death from any cause ] [ Designated as safety issue: No ]
The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy. [ Time Frame: Until death from any cause ]
Complete list of historical versions of study NCT00547651 on ClinicalTrials.gov Archive Site
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival. [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression [ Time Frame: Until death ] [ Designated as safety issue: No ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety [ Time Frame: Until death ] [ Designated as safety issue: Yes ]
  • To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life [ Time Frame: Until death ] [ Designated as safety issue: No ]
Secondary objectives are to further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate; progression-free survival; duration of response; time to tumor progression; safety; quality of life. [ Time Frame: Until death from any cause ]
Not Provided
Not Provided
 
AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

Small cell lung cancer represents approximately 13% of the cancers of the lung and presents as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone (35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine differentiation.

The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group system that categorizes patients as having limited or extensive disease. Limited stage SCLC is disease confined to 1 hemithorax with or without adjacent mediastinal and/or supraclavicular lymph node involvement, but without a pleural effusion. This extent of disease can be included in a tolerable radiation field. Extensive-disease SCLC is any disease beyond the definition of limited-stage disease.

There are few proven treatment options for SCLC patients who fail first-line chemotherapy. New treatment strategies must be evaluated. The need to discover active agents with better toxicity profiles continues to be of great importance. Amrubicin may be an effective treatment for this population.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: Amrubicin
    Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
    Other Name: amrubidin hydrochloride, Calsed, CNF3140
  • Drug: Topotecan
    Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
    Other Name: Topotecan hydrochloride, Hycamtin
  • Experimental: Amrubicin
    Amrubicin
    Intervention: Drug: Amrubicin
  • Active Comparator: Topotecan
    Topotecan
    Intervention: Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
637
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
  • SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression < 90 days after completing first-line chemotherapy);
  • Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
  • Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
  • No more than 1 prior chemotherapy regimen;
  • At least 18 years of age;
  • ECOG performance status of 0 - 1

Exclusion Criteria:

  • Chest radiotherapy with curative intent to the primary disease complex </= 28 days prior to first dose; CNS radiotherapy </= 21 days prior to first dose; radiotherapy to all other areas </= 7 days prior to first dose;
  • Prior anthracycline, topotecan, or irinotecan treatment.
  • Prior anthracycline or topotecan treatment.
  • Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland,   Austria,   Germany,   Italy,   United Kingdom,   Belgium,   France,   Hungary,   Bulgaria,   Spain,   Netherlands,   Czech Republic,   Australia,   Canada,   Denmark,   Switzerland
 
NCT00547651
AMR PH GL 2007 CL001
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Markus Renschler, M.D. Celgene Corporation
Celgene Corporation
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP