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

July 7, 2005
August 7, 2008
December 2002
January 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00119613 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: placebo
    placebo
  • Drug: darbepoetin alfa
    darbepoetin alfa
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
April 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00119613
20010145
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP