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
1 other identifier
interventional
600
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2002
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 7, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedAugust 8, 2008
August 1, 2008
4.1 years
July 7, 2005
August 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
from baseline to the end of the chemotherapy treatment period
Survival time
Secondary Outcomes (3)
Change in FACT-fatigue subscale scores from baseline to the end of study treatment
from baseline to the end of study treatment
Incidence of Adverse Events (including serious and treatment related)
Throughout study
Changes in laboratory values, changes in vital signs and incidence of concomitant medications
Throughout study
Study Arms (2)
Group 1 - darbepoetin alfa
EXPERIMENTALDarbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
Group 2 - Placebo
PLACEBO COMPARATORPlacebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (2)
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. doi: 10.1200/JCO.2007.15.0748.
PMID: 18467726RESULTVentz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
PMID: 36184621DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2005
First Posted
July 14, 2005
Study Start
December 1, 2002
Primary Completion
January 1, 2007
Study Completion
April 1, 2007
Last Updated
August 8, 2008
Record last verified: 2008-08