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NCT Number: 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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

placebo

darbepoetin alfa

Drug

darbepoetin alfa

Primary outcomes

  1. 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

  2. Survival time

Secondary outcomes

  1. Change in FACT-fatigue subscale scores from baseline to the end of study treatment

    Time frame: from baseline to the end of study treatment

  2. Incidence of Adverse Events (including serious and treatment related)

    Time frame: Throughout study

  3. Changes in laboratory values, changes in vital signs and incidence of concomitant medications

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jul 14, 2005
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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