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

M.D. Anderson Cancer Center

Status and phase

Terminated

Phase 3

Conditions

Gastrointestinal Cancer

Rectal Cancer

Treatments

Drug: Procrit (epoetin alfa)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00254436

ID00-264

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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