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

August 7, 2008 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival time
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
from baseline to the end of the chemotherapy treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in FACT-fatigue subscale scores from baseline to the end of study treatment
Time Frame: 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)
Time Frame: Throughout study
Throughout study
Changes in laboratory values, changes in vital signs and incidence of concomitant medications
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (ESTIMATE)

July 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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