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Sponsor ID
20010145

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

Sponsor ID
20010145
Clinicaltrials.gov ID
NCT00119613
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
600
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period

Timeframe: from baseline to the end of the chemotherapy treatment period

Survival time

Timeframe: N/A

Secondary Outcome Measures

Change in FACT-fatigue subscale scores from baseline to the end of study treatment

Timeframe: from baseline to the end of study treatment

Incidence of Adverse Events (including serious and treatment related)

Timeframe: Throughout study

Changes in laboratory values, changes in vital signs and incidence of concomitant medications

Timeframe: Throughout study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    Dec 2002 - Jan 2007
    Inclusion and Exclusion 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