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

Amgen0 sites600 target enrollmentDecember 2002

ConditionsSmall Cell Lung Cancer

Interventionsdarbepoetin alfa placebo

Drugsplacebo darbepoetin alfa

Overview

Phase: Phase 3
Intervention: darbepoetin alfa
Conditions: Small Cell Lung Cancer
Sponsor: Amgen
Enrollment: 600
Primary Endpoint: Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

April 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

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

Arms & Interventions

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.

Intervention: 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.

Intervention: placebo

Outcomes

Primary Outcomes

Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period

Time Frame: from baseline to the end of the chemotherapy treatment period

Survival time

Secondary Outcomes

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)