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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00119613
First received: July 7, 2005
Last updated: August 7, 2008
Last verified: August 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: Group 1 - darbepoetin alfa
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
Placebo Comparator: Group 2 - Placebo
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
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: NCT00119613

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00119613     History of Changes
Other Study ID Numbers: 20010145
Study First Received: July 7, 2005
Last Updated: August 7, 2008
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

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
Etoposide
Etoposide phosphate
Darbepoetin alfa
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014