Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00416624
Other study ID # CDR0000522677
Secondary ID P30CA015083RC05C
Status Completed
Phase Phase 2
First received December 27, 2006
Last updated October 15, 2014
Start date May 2007
Est. completion date June 2009

Study information

Verified date October 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

OBJECTIVES:

Primary

- Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.

Secondary

- Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL.

- Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens.

- Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required.

- Compare the weekly change in hemoglobin in patients treated with these regimens.

- Compare the need for dose reduction in patients treated with these regimens.

- Compare the adverse event profiles of these regimens in these patients.

- Compare quality of life of patients treated with these regimens.

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.

- Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.

- Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.

- Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.

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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder)

- No nonmelanomatous skin cancer

- Hemoglobin = 10.5 g/dL

- Ferritin > 20 ng/mL (i.e., not obviously iron deficient)

- Planning to receive = 12 weeks of anticancer chemotherapy

- Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia > 10% is considered chemotherapy for purposes of this study

- No known anemia secondary to any of the following:

- Cyanocobalamin (vitamin B_12) or folic acid deficiency

- Gastrointestinal bleeding within the past 2 weeks

- Hemolysis

- Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia

- 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)

- Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy = 6 months

- Not pregnant or nursing

- No delivery of a baby of = 18 weeks estimated gestational age within the past 3 months (90 days)

- Negative pregnancy test

- Fertile patients must use effective contraception

- Weight > 40.0 kg and < 150.0 kg

- No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived products, or human albumin

- No uncontrolled hypertension, defined as systolic blood pressure (BP) = 180 mm Hg and/or diastolic BP = 100 mm Hg, despite medical therapy

- No pulmonary emboli and/or deep vein thrombosis within the past 12 months

- Patients actively receiving warfarin for a minimum of 4 weeks are exempted from this requirement

- Prior superficial thrombophlebitis allowed

- No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous thrombotic events within the past 6 months

- No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

- Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid [aspirin] at a dose of = 325 mg/day) for these conditions are eligible provided therapy is continued during the study period

- History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation

- More than 14 days since prior red blood cell transfusion

- More than 14 days since prior major surgery, including, but not limited to, any of the following:

- Amputation

- Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool

- Resection of a body part (or parts), whether solid or liquid tissue or both, that includes = 1% of a patient's preoperative weight

- The following are not considered major surgery:

- Diagnostic/therapeutic thoracentesis or paracentesis

- Diagnostic skin biopsy

- Digit or fingernail/thumbnail resection or laceration repair under local anesthesia

- Diagnostic fat aspiration

- Otic irrigation to remove cerumen impaction

- Tympanocentesis

- Uncomplicated dental extraction

- Uncomplicated tonsillectomy

- Laser corneal remodeling for refraction purposes

- Cosmetic or therapeutic eyelid surgery

- Bone marrow aspiration and biopsy

- More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein)

- No planned stem cell transplantation within the next 4 months (18 weeks)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
darbepoetin alfa

epoetin alfa

Procedure:
fatigue assessment and management

quality-of-life assessment


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin within the goal range) the proportion of patients who exhibit a hematopoietic response (defined as Hb rise >2 g/dL from baseline or achieving Hb = 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period 20 weeks
Secondary Weekly change in hemoglobin levels To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa 16 weeks No
Secondary Time required to achieve hemoglobin levels within the goal range To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa 16 weeks No
Secondary Proportion of patients requiring red blood cell (RBC) transfusions and the number of transfusions required To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa 16 weeks No
Secondary Dose reduction in each regimen To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa No
Secondary Adverse events as measured by CTCAE v3.0 To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa 16 weeks No
Secondary Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia, Linear Analogue Self Assessment measures, Brief Fatigue Inventory, and Symptom Distress Scale at baseline and at 4, 8, 16, and 24 weeks To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa 16 weeks No
Secondary Mean hemoglobin increment week by week To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa 16 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT05540340 - A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Completed NCT01410630 - FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Active, not recruiting NCT04270266 - Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT01949883 - A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma Phase 1
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Completed NCT04434937 - Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) Phase 2
Completed NCT01855750 - A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma Phase 3
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Terminated NCT00775268 - 18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma Phase 1/Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Active, not recruiting NCT03936465 - Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer Phase 1