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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00070382 |
Purpose
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 | Intervention | 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 III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following diagnoses are excluded:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
More Information
| Responsible Party: | John Glaspy, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00070382 History of Changes |
| Other Study ID Numbers: | CDR0000333213, P30CA016042, UCLA-0306021, AMGEN-20030125 |
| Study First Received: | October 3, 2003 |
| Last Updated: | November 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
anemia unspecified adult solid tumor, protocol specific Waldenstrom macroglobulinemia monoclonal gammopathy of undetermined significance extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma primary systemic amyloidosis stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma post-transplant lymphoproliferative disorder angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma |
stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent adult Hodgkin lymphoma |
|
Anemia Neoplasms Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Hematologic Diseases Pathologic Processes Neoplasms by Histologic Type |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Darbepoetin alfa Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |