Clinical trial NCT00119613: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Oncology
Clinical Trial
Hemoglobin
Darbepoetin alfa
Survival
Carboplatin
Cisplatin
Etoposide
Extensive Stage Small Cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
measure: Survival time
Secondary outcomes:
measure: Change in FACT-fatigue subscale scores from baseline to the end of study treatment
timeFrame: from baseline to the end of study treatment
measure: Incidence of Adverse Events (including serious and treatment related)
timeFrame: Throughout study
measure: Changes in laboratory values, changes in vital signs and incidence of concomitant medications
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.