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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00416624 |
Purpose
RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.
PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.
| Condition | Intervention |
|---|---|
|
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific |
Biological: darbepoetin alfa Biological: epoetin alfa Procedure: fatigue assessment and management Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa |
| Estimated Enrollment: | 320 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]), platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy vs solid tumor). Patients are randomized to 1 of 4 treatment arms.
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within the desired ranges.
Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder)
Planning to receive ≥ 12 weeks of anticancer chemotherapy
No known anemia secondary to any of the following:
No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
PATIENT CHARACTERISTICS:
Not pregnant or nursing
No pulmonary emboli and/or deep vein thrombosis within the past 12 months
No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)
PRIOR CONCURRENT THERAPY:
More than 14 days since prior major surgery, including, but not limited to, any of the following:
The following are not considered major surgery:
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | David P. Steensma, MD | Mayo Clinic |
| Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000522677, MCCRC-RC05CB, MCCRC-06-002991, ORTHO-MCCRC-RC05CB |
| Study First Received: | December 27, 2006 |
| Last Updated: | February 1, 2010 |
| ClinicalTrials.gov Identifier: | NCT00416624 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma Waldenstrom macroglobulinemia post-transplant lymphoproliferative disorder 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 adult T-cell leukemia/lymphoma AIDS-related peripheral/systemic lymphoma |
AIDS-related primary CNS lymphoma 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 cutaneous T-cell non-Hodgkin lymphoma 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 mycosis fungoides/Sezary syndrome stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma |
|
Epoetin Alfa Precancerous Conditions Blood Protein Disorders Hematologic Agents Paraproteinemias Hemostatic Disorders Leukemia Pathologic Processes Hemorrhagic Disorders Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Hematinics Hematologic Diseases Anemia Vascular Diseases Darbepoetin alfa Pharmacologic Actions Multiple Myeloma Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Neoplasms, Plasma Cell |