Small Cell Lung Cancer
Conditions
Keywords
Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide, Extensive Stage Small Cell Lung Cancer
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.
Interventions
DRUGplacebo
placebo
DRUGdarbepoetin alfa
darbepoetin alfa
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Changes in laboratory values, changes in vital signs and incidence of concomitant medications | Throughout study |
| Incidence of Adverse Events (including serious and treatment related) | Throughout study |
| Change in FACT-fatigue subscale scores from baseline to the end of study treatment | from baseline to the end of study treatment |
Outcome results
None listed