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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Cancer, Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients with Reduction in Red Blood Cell Transfusions

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Saroj Vadhan-Raj, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MDAnderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID00-264

NCT ID:

NCT00254436

Start Date:

December 2002

Completion Date:

June 2004

Related Keywords:

  • Gastrointestinal Cancer
  • Rectal Cancer
  • Epoetin Alfa
  • Epogen
  • Erythropoietin
  • Rectal Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030