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

This study has been terminated.
Sponsor:
Collaborator:
Ortho Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00254436
First received: November 14, 2005
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Gastrointestinal Cancer
Rectal Cancer
Drug: Procrit (epoetin alfa)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Reduction in Red Blood Cell Transfusions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patient Iron Levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Iron stores drawn at baseline and every four weeks.


Enrollment: 50
Study Start Date: December 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin Alfa Drug: Procrit (epoetin alfa)
Weekly dose
Other Names:
  • Epogen
  • Erythropoietin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254436

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254436     History of Changes
Other Study ID Numbers: ID00-264
Study First Received: November 14, 2005
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rectal Neoplasms
Gastrointestinal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014