A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00119613

Purpose

The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: placebo Drug: darbepoetin alfa	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Etoposide Cisplatin Etoposide phosphate Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Further study details as provided by Amgen:

Primary Outcome Measures:

Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period [ Time Frame: from baseline to the end of the chemotherapy treatment period ] [ Designated as safety issue: No ]
Survival time [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in FACT-fatigue subscale scores from baseline to the end of study treatment [ Time Frame: from baseline to the end of study treatment ] [ Designated as safety issue: No ]
Incidence of Adverse Events (including serious and treatment related) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Changes in laboratory values, changes in vital signs and incidence of concomitant medications [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	December 2002
Study Completion Date:	April 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1 - darbepoetin alfa: Experimental Darbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.	Drug: darbepoetin alfa darbepoetin alfa
Group 2 - Placebo: Placebo Comparator Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically proven SCLC, extensive-stage
Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Life expectancy greater than or equal to 3 months
Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL
Adequate renal, liver and hematopoietic function
Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form

Exclusion Criteria:

Known primary hematologic disorder which could cause anemia
Brain metastases that are either symptomatic or treated with medications
Unstable or uncontrolled disease/condition, related to or affecting cardiac function
Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies
Iron deficiency
Known positive test for human immunodeficiency virus infection
Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization
Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
Previous chemotherapy for SCLC
Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely
Less than 30 days since receipt of any drug or device that is not approved for any indication
Pregnant or breast-feeding
Not using adequate contraceptive precautions
Previously randomized into this study
Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug
Any medical, mental, or other conditions that makes the subject unsuitable for participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119613

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

Publications of Results:

Pirker R, Ramlau RA, Schuette W, Zatloukal P, Ferreira I, Lillie T, Vansteenkiste JF. Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. J Clin Oncol. 2008 May 10;26(14):2342-9.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010145
Study First Received:	July 7, 2005
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00119613
Health Authority:	Switzerland: Agency for Therapeutic Products; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Romania: Ministry of Health and the Family; Australia: Therapeutic Goods Administration; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Canada: Health Canada; Czech Republic: Statni ustav pro kontrolu leciv; Denmark: Laegemiddelstyrelsen; Estonia: State Agency of Medicines; Finland: Lääkelaitos; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Italy: Ministry of Health; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED); Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Sweden: Medical Products Agency

Keywords provided by Amgen:

Oncology
Clinical Trial
Hemoglobin
Darbepoetin alfa
Survival

Carboplatin
Cisplatin
Etoposide
Extensive Stage Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Darbepoetin alfa
Carboplatin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Hematinics
Antineoplastic Agents

Therapeutic Uses
Hematologic Agents
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009