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Epoetin Alfa

Starting dose 40,000 units subcutaneously once a week with chemotherapy.

Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).

Procrit (epoetin alfa)

Jorge Cortes, MD

The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer who have received treatment with epoetin alfa.

Epoetin alfa is a medication that helps the body make more red blood cells.

Before treatment you will have a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of your standard of care). Women who are able to have children must have a negative blood pregnancy test.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Patients in the first group will be given epoetin alfa once a week at the time chemotherapy is started. Patients in the other group will not receive epoetin alfa, but will undergo the same laboratory exams and quality of life evaluations as the group of patients who were given epoetin alfa.

Patients in both groups will receive transfusions if their hemoglobin drops below a certain level or it the doctor feels it is necessary. These transfusions are considered to be standard of care. You will be asked to keep a diary listing the dates of all transfusions you receive.

If you are assigned to receive epoetin alfa, you will be given epoetin alfa once a week during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa for up to 6 courses of chemotherapy (usually around 5 months, but may be longer). Epoetin alfa will be given to you as an injection under the skin. Once a week, you will have around 1 tablespoon of blood drawn to check the level of hemoglobin in your blood. If your hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.

Patients in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of your standard of care for treatment of cancer).

If you agree to the optional procedures, you will continue receiving epoetin alfa even if your hemoglobin levels show that you are not responding to epoetin alfa treatment. However, if you do not choose to take part in the optional procedures and you are not responding to epoetin alfa treatment, you will be taken off the study.

If you experience any intolerable side effects that are a result of epoetin alfa or your disease gets worse, you will be taken off the study.

This is an investigational study. Epoetin alfa is FDA approved and commercially available. Around 164 patients will take part in this study. All will be enrolled at M. D. Anderson.

Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.

Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.

M.D. Anderson Cancer Center

Starting dose 40,000 Units subcutaneously once a week with chemotherapy.

Procrit

No Procrit

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Jorge Cortes M.D./Professor

Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.

Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.

Mean Number of RBC Units Transfused During Initial 5 Months of Treatment

Number of PRBC Transfusions During Initial 5 Months of Treatment

Overall Study

Digestive System Diseases

Rectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Saroj Vadhan-Raj, M.D.

To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.

Anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. Results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery

Iron stores drawn at baseline and every four weeks.

Ortho Pharmaceuticals

Anemia

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

PROCRIT (Epoetin alfa)

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

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).

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.

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

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

Ortho Biotech Products, L.P.

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

Epoetin alfa

The purpose of this study is to determine the effectiveness and safety of PROCRIT (Epoetin alfa) at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.

Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in a response rate (defined as \>= 2 g/dL Hb increase or Hb \>= 12 g/dL) of approximately 65% of anemic chemotherapy patients and produces a mean hemoglobin (Hg) rise of 1.8 g/dL. Higher weekly dosing of epoetin alfa may result in a higher response rate and a more timely mean hemoglobin rise while remaining safe. Additionally, limited data are available to show whether epoetin alfa maintenance therapy can be administered less frequently than weekly and still maintain hemoglobin levels. This is an open label, multicenter, non-randomized study to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving chemotherapy every three weeks.

Patients will receive injections of PROCRIT (Epoetin alfa) 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks. Doses will be held and adjusted downward if hemoglobin level rises to \>13 g/dL or if a very rapid hemoglobin response occurs (e.g., an increase of more than 1.3 g/dL in a 2-week period).

Safety evaluations include clinical laboratory tests (hemoglobin and hematocrit), vital sign measurements (blood pressure), and adverse events. In addition, the antibodies that have developed against erythropoietin will be evaluated in patients who receive multiple doses of PROCRIT (Epoetin alfa). Patients will receive injections of Epoetin alfa 60,000 Units (U) once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under the skin for up to an additional 12 weeks.

An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks

An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy	NCT01099202	Leukemia	Procrit (epoeti...	-	M.D. Anderson Cancer Center
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients	NCT00254436	Gastrointestina... Rectal Cancer	Procrit (epoeti...	18 Years -	M.D. Anderson Cancer Center
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy	NCT00210600	Anemia	PROCRIT (Epoeti...	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients	NCT00254436	Gastrointestina... Rectal Cancer	Procrit (epoeti...	18 Years -	M.D. Anderson Cancer Center
An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks	NCT00338416	Cancer Anemia	Epoetin alfa	19 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks	NCT00338416	Cancer Anemia	Epoetin alfa	19 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Spots Global Cancer Trial Database for procrit (epoetin alfa)