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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00119613

Collaborator

(none)

600

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: placebo Drug: darbepoetin alfa	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: darbepoetin alfa darbepoetin alfa
Placebo Comparator: 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.	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: 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.

Drug: darbepoetin alfa

darbepoetin alfa

Placebo Comparator: 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.

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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