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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.
Information provided by:
Amgen Identifier:
First received: July 7, 2005
Last updated: August 7, 2008
Last verified: August 2008
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
  • Survival time

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 ]
  • Incidence of Adverse Events (including serious and treatment related) [ Time Frame: Throughout study ]
  • Changes in laboratory values, changes in vital signs and incidence of concomitant medications [ Time Frame: Throughout study ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00119613

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

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

Keywords provided by Amgen:
Clinical Trial
Darbepoetin alfa
Extensive Stage Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Darbepoetin alfa
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics processed this record on May 23, 2017