AMR PH GL 2007 CL 001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00547651

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	AMR PH GL 2007 CL 001 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Amrubicin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	637
Study Start Date:	September 2007
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Amrubicin Amrubicin	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
Active Comparator: Topotecan Topotecan	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

Detailed Description:

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547651

Show 140 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Markus Renschler, M.D.

Celgene Corporation

More Information

No publications provided

Responsible Party:	Markus Renschler MD, VP Clinical Development, Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00547651 History of Changes
Other Study ID Numbers:	AMR PH GL 2007 CL 001
Study First Received:	October 18, 2007
Last Updated:	July 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Small Cell Lung Cancer
Lung Cancer
Limited Disease Sensitive Small Cell Lung Cancer
Extensive Disease Sensitive Small Cell Lung Cancer

Limited Disease Refractory Small Cell Lung Cancer
Extensive Disease Refractory Small Cell Lung Cancer
Refractory Small Cell Lung Cancer
Sensitive Small Cell Lung Cancer

Additional relevant MeSH terms:

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

Amrubicin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 13, 2012