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Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy

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ClinicalTrials.gov Identifier: NCT00270127
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE December 22, 2005
First Posted Date  ICMJE December 26, 2005
Last Update Posted Date May 18, 2011
Study Start Date  ICMJE August 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Proportion of patients transfused after one month
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00270127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Changes in hemoglobin, hematocrit, and developing red blood cells from the start of the study until study completion; Changes in quality-of-life; Safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
Official Title  ICMJE Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy
Brief Summary The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Detailed Description Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This is a randomized, double-blind, placebo-controlled, multicenter study to assess the effect of treatment with epoetin alfa in reducing or preventing anemia and transfusions in patients receiving non-platinum chemotherapy for non-myeloid cancers. The study also aims to determine whether changes in erythropoietin and hemoglobin levels after 2 weeks, serum ferritin (iron) levels after 2 weeks and changes in hemoglobin and developing red blood cells after either 2 or 4 weeks predict responsiveness to epoetin alfa. There will be 2 treatment groups: one group will receive subcutaneous epoetin alfa injections 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and the other group will receive an equal volume of matching subcutaneous placebo. Treatment is to continue for 12 to 24 weeks (3 to 6 chemotherapy cycles), plus 4 weeks post-chemotherapy. Patients in the study will be observed a year after the study ends for survival data. The primary measure of effectiveness will be determined by the number of patients who are transfused, depending on primary tumor type (solid or blood) and level of hemoglobin (above or below 10.5 grams per deciliter). Additional measures of effectiveness include the change in hemoglobin, hematocrit, and developing red blood cells from the start of the study until study completion, and the change in quality of life. Safety evaluations (incidence and severity of adverse events, laboratory tests, vital signs and physical examinations) will be performed throughout the study. The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and in improving anemia and quality of life. 150 units per kilogram of epoetin alfa (or placebo) 3 times weekly subcutaneously for 4 weeks, then continuing this dose or 300 units per kilogram, depending on developing red blood cell counts and/or hemoglobin. Study duration is 12 to 24 weeks (3 to 6 cycles) plus 4 weeks post-chemotherapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Cancer
  • Neoplasm
Intervention  ICMJE Drug: Epoetin alfa
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2011)
375
Original Enrollment  ICMJE
 (submitted: December 22, 2005)
360
Actual Study Completion Date  ICMJE September 1998
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of non-myeloid malignancy
  • undergoing treatment with non-platinum-containing chemotherapy, or non-platinum-containing chemotherapy is imminent
  • Eastern Cooperative Oncology Group (which is a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)
  • life expectancy of at least 6 months
  • baseline hemoglobin <= 10.5 grams per deciliter (or a fall in hemoglobin level >= 1.5 grams per deciliter per cycle or per month since the beginning of the current course of chemotherapy such that it dropped to <= 12 grams per deciliter) and baseline count of <125,000 microliters for developing red cells

Exclusion Criteria:

  • Patients having a clinically significant disease other than cancer
  • treated by platinum-containing chemotherapy within 3 months of study start
  • having uncontrolled high blood pressure, a history of seizure, or untreated iron, folate, or Vitamin B12 deficiency
  • received a transfusion or radiotherapy within 2 weeks of study start, or had surgery within 1 week of study start
  • intending to use steroid drugs during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270127
Other Study ID Numbers  ICMJE CR005917
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP