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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2004-06-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing a Treatment Plan of Preoperative Chemotherapy and Radiation Therapy, Followed by Surgery

NCT00036400

Stomach Neoplasms Rectal Neoplasms

COMPLETED PHASE3

ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

NCT04069455

Colorectal Carcinoma

UNKNOWN NA

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

NCT00682786

Rectal Carcinoma

COMPLETED PHASE2

Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

NCT00506623

Rectal Neoplasm Neoadjuvant Therapy

UNKNOWN PHASE2

Preoperative Radiotherapy and E7046 in Rectum Cancer

NCT03152370

Neoadjuvant Therapy in Rectal Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Cancer Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epoetin Alfa

Group Type EXPERIMENTAL

Procrit (epoetin alfa)

Intervention Type DRUG

Weekly dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Procrit (epoetin alfa)

Weekly dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epogen Erythropoietin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes