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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119613
• Other study ID #: 20010145
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2005
• Last updated: August 7, 2008
• Start date: December 2002
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Agency for Therapeutic ProductsTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationRomania: Ministry of Health and the FamilyAustralia: Therapeutic Goods AdministrationAustria: Bundesamt für Sicherheit im GesundheitswesenBelgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et EnvironnementCanada: Health CanadaCzech Republic: Statni ustav pro kontrolu lecivDenmark: LaegemiddelstyrelsenEstonia: State Agency of MedicinesFinland: LääkelaitosGermany: Federal Institute for Drugs and Medical DevicesGermany: Paul_Ehrlich-Institut Bundesamt fur Sera und ImpfstoffeHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: Ministry of HealthLithuania: State Medicines Control Agency of LithuaniaNetherlands: Medicines Evaluation BoardNetherlands: Medisch Centrum Rijnmond_Zuid, lcatie ZuiderPoland: Drug InstitutPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)Slovakia: Štátny ústav pre kontrolu liecivSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• placebo
placebo
• darbepoetin alfa
darbepoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period		from baseline to the end of the chemotherapy treatment period	No
Primary	Survival time			Yes
Secondary	Change in FACT-fatigue subscale scores from baseline to the end of study treatment		from baseline to the end of study treatment	No
Secondary	Incidence of Adverse Events (including serious and treatment related)		Throughout study	Yes
Secondary	Changes in laboratory values, changes in vital signs and incidence of concomitant medications		Throughout study	Yes

External Links

•   AmgenTrials clinical trials website