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A Double-Blind, Rand., Placebo-Controlled Study of the Efficacy&Safety of Weekly Procrit Given to Gastric/Rectal Pts.
This study has been terminated.
First Received: November 14, 2005   No Changes Posted
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254436
  Purpose

To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell tranfusions 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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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:
  • Cbc/diff/plt/retic drawn at baseline and weekly throughout study.
  • Iron stores drawn at baseline and every four weeks.

Secondary Outcome Measures:
  • Quality of life surveys completed at baseline, Wk 3, Wk 6, before surgery and at the end of study.

Estimated Enrollment: 184
Study Start Date: December 2002
Estimated Study Completion Date: December 2003
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 MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Saroj Vadhan-Raj, M.D. UT MDAnderson Cancer Center
  More Information

No publications provided

Study ID Numbers: ID00-264
Study First Received: November 14, 2005
Last Updated: November 14, 2005
ClinicalTrials.gov Identifier: NCT00254436     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Epoetin Alfa
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Hematinics
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on September 02, 2009