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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254436
Recruitment Status : Terminated
First Posted : November 16, 2005
Last Update Posted : July 31, 2012
Ortho Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Rectal Cancer Drug: Procrit (epoetin alfa) Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Epoetin Alfa Drug: Procrit (epoetin alfa)
Weekly dose
Other Names:
  • Epogen
  • Erythropoietin

Primary Outcome Measures :
  1. Number of Patients with Reduction in Red Blood Cell Transfusions [ Time Frame: 2 years ]
  2. Patient Iron Levels [ Time Frame: Every 4 weeks ]
    Iron stores drawn at baseline and every four weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female 18 years of age or older
  • Must have a confirmed diagnosis of gastric or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery
  • Must have a baseline hemoglobin >/= 10 g/dl and < 15 g/dl
  • Must have adequate hematologic function
  • Must have life expectancy of more than 6 months
  • Karnofsky performance status of at least 50%
  • Must have adequate renal function
  • Patients with reproductive potential must use an adequate contraceptive method during treatment and three months after completing treatment
  • Patients must be able to read, understand, and complete the three Quality of Life questionnaires in English.

Exclusion Criteria:

  • Prior chemotherapy for patients with rectal cancer
  • Gastric cancer patients who have received more than 2 cycles of chemotherapy
  • Anemia due to factors other than cancer/chemotherapy
  • Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 6 months
  • Known hypersensitivity to mammalian-cell derived products or to human albumin
  • Pregnant or lactating women
  • Untreated Central Nervous System metastases
  • Any significant, uncontrolled disease/dysfunction of any of the major organs
  • Uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
  • New onset or poorly controlled seizures
  • History of active second malignancy
  • Major infection requiring hospitalization and antibiotics or surgery within 14 days of study entry
  • Blood transfusion within 1 month of study entry
  • Androgen therapy within 2 months of study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254436

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ortho Pharmaceuticals
Principal Investigator: Saroj Vadhan-Raj, M.D. UT MDAnderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00254436     History of Changes
Other Study ID Numbers: ID00-264
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Epoetin Alfa

Additional relevant MeSH terms:
Rectal Neoplasms
Gastrointestinal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Epoetin Alfa