Full Text View
Tabular View
No Study Results Posted
Related Studies
Darbepoetin Alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: June 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039247
  Purpose

RATIONALE: Darbepoetin alfa may stimulate red blood cell production and may be effective in treating anemia in patients who are receiving chemotherapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of darbepoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.


Condition Intervention Phase
Cancer-Related Problem/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Biological: darbepoetin alfa
Phase II

MedlinePlus related topics: Anemia Cancer
Drug Information available for: Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control
Official Title: A Randomized, Open-Label, Dose-Timing Study Of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection For Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of darbepotein alfa administered on the same day as chemotherapy vs an alternate time to chemotherapy administration for the treatment of anemia in patients with nonmyeloid malignancies receiving multiple courses of chemotherapy.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin (less than 10.0 g/dL vs 10.0-11.0 g/dL) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive darbepoetin alfa subcutaneously (SC) on day 15 of each chemotherapy course.
  • Arm II: Patients receive darbepoetin alfa SC on day 1 of each chemotherapy course.

In both arms, treatment repeats every 3 weeks for up to 5 courses in the absence of unacceptable toxicity or treatment failure.

PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 8 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a nonmyeloid malignancy
  • Cancer- or chemotherapy-related anemia

    • Hemoglobin 9.0-11.0 g/dL
  • Currently receiving chemotherapy on a 3-week course schedule

    • Myelosuppressive chemotherapy must not be administered on course days 9-21
    • At least 2 additional courses of chemotherapy planned
  • No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 2 times ULN

Cardiovascular:

  • No uncontrolled angina
  • No congestive heart failure
  • No New York Heart Association class III-IV cardiac disease
  • No uncontrolled hypertension
  • No cardiac arrhythmia
  • No other unstable or uncontrolled cardiac disease or condition

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No seizure disorder
  • No clinically significant inflammatory disease
  • No hypersensitivity to recombinant mammalian-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior epoetin alfa or darbepoetin alfa
  • No other concurrent epoetin alfas

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Concurrent radiotherapy allowed

Surgery:

  • Not specified

Other:

  • At least 30 days since prior investigational drugs or devices
  • No prior enrollment on this study
  • No other concurrent investigational drugs
  • No more than 2 red blood cell (RBC) transfusions within the past 4 weeks
  • No RBC transfusions during the chemotherapy course before randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039247

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069366, UCLA-0111006, AMGEN-20010162, NCI-G02-2071
Study First Received: June 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00039247     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
anemia

Study placed in the following topic categories:
Hematinics
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Darbepoetin alfa
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009