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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00070382

Collaborator

Amgen (Industry)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: darbepoetin alfa Drug: epoetin alfa	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Darbepoetin alfa darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.	Drug: darbepoetin alfa darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
Active Comparator: Epoetin alfa epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.	Drug: epoetin alfa epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Arm

Intervention/Treatment

Experimental: Darbepoetin alfa

darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.

Drug: darbepoetin alfa

darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period

Active Comparator: Epoetin alfa

epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.

Drug: epoetin alfa

epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Outcome Measures

Primary Outcome Measures

Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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