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
NCT ID: NCT00119613
Last Updated: 2008-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2002-12-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
darbepoetin alfa
darbepoetin alfa
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.
placebo
placebo
Interventions
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placebo
placebo
darbepoetin alfa
darbepoetin alfa
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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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.
Ventz 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.
Related Links
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To access clinical trial results information click on this link
AmgenTrials clinical trials website
Notice regarding posted summaries of trial results
To access clinical trial results information click on this link
Other Identifiers
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20010145
Identifier Type: -
Identifier Source: org_study_id