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Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia

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Trial Information

Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

CR003196

NCT ID:

NCT00210600

Start Date:

May 2005

Completion Date:

August 2006

Related Keywords:

  • Anemia
  • Anemia
  • Hemoglobin level
  • Anemia

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