Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

Phase 3

Completed

• Conditions: Lymphoma; Anemia; Multiple Myeloma and Plasma Cell Neoplasm; Leukemia; Precancerous Condition; Lymphoproliferative Disorder; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00058331
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

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 Timeline

• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Study Start: 2003-06
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the effects of these regimens on increasing hemoglobin levels	Up to 1 year post-treatment

Secondary Outcome Measures

Name	Time	Method
Compare the effects of anemia-specific components of QOL	Up to 1 year post-treatment
Compare the effects of these regimens on overall quality of life (QOL)	Up to 1 year post-treatment

Trial Locations

Locations (18)

CCOP - Mayo Clinic Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Michigan Cancer Research Consortium; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

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