A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
This study has been terminated.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Ortho Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00254436
First received: November 14, 2005
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Cancer Rectal Cancer |
Drug: Procrit (epoetin alfa) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Patients with Reduction in Red Blood Cell Transfusions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Patient Iron Levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]Iron stores drawn at baseline and every four weeks.
| Enrollment: | 50 |
| Study Start Date: | December 2002 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Epoetin Alfa |
Drug: Procrit (epoetin alfa)
Weekly dose
Other Names:
|
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 treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254436
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ortho Pharmaceuticals
Investigators
| Principal Investigator: | Saroj Vadhan-Raj, M.D. | UT MDAnderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00254436 History of Changes |
| Other Study ID Numbers: | ID00-264 |
| Study First Received: | November 14, 2005 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Epoetin Alfa Epogen Erythropoietin |
Additional relevant MeSH terms:
|
Rectal Neoplasms Gastrointestinal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013