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

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AMR PH GL 2007 CL 001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
This study is currently recruiting participants.
Verified by Celgene Corporation, January 2009
Sponsored by: 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




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Topotecan hydrochloride Topotecan Amrubicin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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


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 ]


Estimated Enrollment: 620
Study Start Date: September 2007
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Amrubicin: Experimental
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
Topotecan: Active Comparator
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


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 to first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after completing chemotherapy) or refractory (defined as no objective response to prior platinum-based therapy or progression < 90 days after completing prior platinum-based therapy);
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, or 2.
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 or topotecan treatment.
Contacts and Locations

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


Contacts
Contact: Mary E Bartlett, BSN, RN 913-266-0513 mbartlett@celgene.com

Show 91 Study Locations

Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Markus Renschler, M.D. Celgene Corporation

More Information

Responsible Party: Celgene Corporation ( Mary Bartlett, Global Project Manager )
Study ID Numbers: AMR PH GL 2007 CL 001
Study First Received: October 18, 2007
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00547651 [history]
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



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Amrubicin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Topotecan
Adenocarcinoma
Neoplasms, Glandular and Epithelial



Additional relevant MeSH terms:
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Respiratory Tract Neoplasms
Therapeutic Uses
Neoplasms, Nerve Tissue
Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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