Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210600
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).


Condition Intervention Phase
Anemia
Drug: PROCRIT (Epoetin alfa)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.

Secondary Outcome Measures:
  • The proportion of patients in the early intervention group for whom all hemoglobin values during the 16 week PROCRIT (Epoetin alfa) treatment were > 11.0 g/dL and < 13.0 g/dL.

Enrollment: 186
Study Start Date: May 2005
Study Completion Date: August 2006
Detailed Description:

This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:

  1. Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and
  2. Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry.

For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed diagnosis of non-myeloid malignancy
  • Baseline hemoglobin (Hb) value of >= 11.0 g/dL and <= 12.0 g/dL
  • No blood transfusions in the 28 days prior to the start of Treatment Phase
  • Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
  • Iron transferrin saturation (TSAT) > 20% or if TSAT<20%, serum ferritin must be greater than 100 ng/mL.

Exclusion Criteria:

  • No myeloid malignancy or known history of myelodysplasia
  • No planned radiation during the study
  • Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
  • No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
  • No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
  • Has not received an experimental drug or device within the past 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210600

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Products, L.P.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00210600     History of Changes
Other Study ID Numbers: CR003196
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Hemoglobin level

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014