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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: placebo
* Drug: darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - darbepoetin alfa<br>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<br>* darbepoetin alfa<br>|
| Placebo Comparator: Group 2 - Placebo<br>Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period. | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide, Extensive Stage Small Cell Lung Cancer