Status:
TERMINATED
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Ortho Pharmaceuticals
Conditions:
Gastrointestinal Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00254436
Start Date
October 31 2001
End Date
June 29 2004
Last Update
October 25 2018
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030