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

Amgen

Status and phase: Completed; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Drug: placebo; Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00119613

20010145

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Group 1 - darbepoetin alfa

Experimental group

Description:

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.

Treatment:

Drug: darbepoetin alfa

Group 2 - Placebo

Placebo Comparator group

Description:

Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.

Treatment:

Drug: placebo