Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00058331
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 365
• Locations: 18
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 20.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.

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

Detailed Description

OBJECTIVES:

• Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.

• Compare the effects of these regimens on increasing hemoglobin levels in these patients.

• Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).

All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 365 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: epoetin alfa - long term dosing Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year.	Biological: epoetin alfa
Experimental: epoetin alfa - short term dosing Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year.	Biological: epoetin alfa

Outcome Measures

Primary Outcome Measures

1. Compare the effects of these regimens on increasing hemoglobin levels [Up to 1 year post-treatment]

Secondary Outcome Measures

1. Compare the effects of these regimens on overall quality of life (QOL) [Up to 1 year post-treatment]

2. Compare the effects of anemia-specific components of QOL [Up to 1 year post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)

• Anemia secondary to cancer or cancer treatment*

• Hemoglobin less than 12 g/dL (males)

• Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment

• Anemia must not be secondary to any of the following:

• B_12, folic acid, or iron deficiency

• Ferritin must be normal or elevated

• Gastrointestinal bleeding or hemolysis

• Primary or chemotherapy-induced myelodysplastic syndromes

• No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Cardiovascular

• No history of uncontrolled cardiac arrhythmias

• No history of deep venous thrombosis within the past year (unless on anticoagulation)

• No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)

Pulmonary

• No history of pulmonary embolism within the past year (unless on anticoagulation)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

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

• No new onset of seizures within the past 3 months

• No poorly controlled seizures

• Able and willing to complete quality of life forms

• Alert and mentally competent to give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 6 months since prior epoetin alfa

• More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)

• No concurrent peripheral blood stem cell transplantation

• No concurrent bone marrow transplantation

Surgery

• More than 14 days since prior major surgery

Other

• More than 2 weeks since prior red blood cell transfusions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic	Jacksonville	Florida	United States	32224
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
6	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
9	CCOP - Duluth	Duluth	Minnesota	United States	55805
10	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
11	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
12	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
13	Altru Cancer Center	Grand Forks	North Dakota	United States	58201
14	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
15	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
16	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
17	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
18	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: David P. Steensma, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00058331
• Other Study ID Numbers: NCCTG-N02C2; CDR0000288821
• First Posted: Apr 9, 2003
• Last Update Posted: Jul 18, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions; Anemia; Lymphoproliferative Disorders; Epoetin Alfa

Study Results

No Results Posted as of Jul 18, 2016