Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period

Outcome Time Frame:

from baseline to the end of the chemotherapy treatment period

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Switzerland: Agency for Therapeutic Products

Study ID:

20010145

NCT ID:

NCT00119613

Start Date:

December 2002

Completion Date:

April 2007

Related Keywords:

  • Small Cell Lung Cancer
  • Oncology
  • Clinical Trial
  • Hemoglobin
  • Darbepoetin alfa
  • Survival
  • Carboplatin
  • Cisplatin
  • Etoposide
  • Extensive Stage Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location