Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Lymphoma Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070382
• Other study ID #: CDR0000333213
• Secondary ID: UCLA-0306021AMGE
• Status: Completed
• Phase: Phase 3
• Start date: August 2003

Study information

• Verified date: August 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

Description:

OBJECTIVES:

Primary

• Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.

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

• Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).

• Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of a non-myeloid malignancy

• Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy

• Hemoglobin no greater than 11.0 g/dL

• 18 and over

• ECOG 0-2

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

• Creatinine less than 2 times ULN

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• More than 30 days since prior darbepoetin alfa or epoetin alfa

• More than 30 days since prior participation in investigational device or drug trials

Exclusion Criteria:

• The following diagnoses are excluded:

• Acute myeloid leukemia

• Chronic myeloid leukemia

• Acute lymphoblastic leukemia

• Hairy cell leukemia

• Burkitt's lymphoma

• Lymphoblastic lymphoma

• other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

• angina

• congestive heart failure

• New York Heart Association class III or IV heart disease

• hypertension

• cardiac arrhythmia

• other unstable or uncontrolled disease or condition that would affect cardiac function

• pregnant or nursing

• known seizure disorder

• known sensitivity to study agents

• clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)

• confirmed neutralizing antibodies to epoetin alfa

• other disorder that would preclude study compliance or giving informed consent

• other concurrent epoetin alfas

• prior randomization to this study

• other concurrent investigational agents or procedures

Related Conditions & MeSH terms

• Anemia
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• darbepoetin alfa
darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
• epoetin alfa
epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (1)

20030125 Study Group Trial, Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.		12 weeks