NCT00254436

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2001

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

November 14, 2005

Last Update Submit

October 24, 2018

Conditions

Gastrointestinal CancerRectal Cancer

Keywords

Epoetin AlfaEpogenErythropoietin

Outcome Measures

Primary Outcomes (2)

  • Number of Patients with Reduction in Red Blood Cell Transfusions

    2 years

  • Patient Iron Levels

    Iron stores drawn at baseline and every four weeks.

    Every 4 weeks

Study Arms (1)

Epoetin Alfa

EXPERIMENTAL
Drug: Procrit (epoetin alfa)

Interventions

Procrit (epoetin alfa)DRUG

Weekly dose

Also known as: Epogen, Erythropoietin
Epoetin Alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal NeoplasmsRectal Neoplasms

Interventions

Epoetin AlfaErythropoietin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Saroj Vadhan-Raj, M.D.

    UT MDAnderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

October 31, 2001

Primary Completion

June 29, 2004

Study Completion

June 29, 2004

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)