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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastrointestinal Cancer; Rectal Cancer

Intervention: Procrit (epoetin alfa) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Saroj Vadhan-Raj, M.D., Principal Investigator, Affiliation: UT MDAnderson Cancer Center

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Patients with Reduction in Red Blood Cell Transfusions

Patient Iron Levels

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

UT MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

UT MD Anderson Cancer Center website

Starting date: December 2002
Last updated: July 27, 2012

Page last updated: August 23, 2015

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