Gastrointestinal CancerPhase 3NCT00254436
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
A Phase 3 study testing Procrit (epoetin alfa) in people with Gastrointestinal Cancer and Rectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancer, Rectal Cancer
- What is being tested?
- Procrit (epoetin alfa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2001to 29 Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Cancer, Rectal Cancer
- Being tested
- Procrit (epoetin alfa)
- Keywords
- Epoetin Alfa, Epogen, Erythropoietin
- Medical subject headings
- Gastrointestinal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procrit (epoetin alfa)Drug
Also called Epogen, Erythropoietin
Weekly dose
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Alfa | Experimental | Not described Receives: Drug: Procrit (epoetin alfa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Reduction in Red Blood Cell Transfusions
Measured: 2 years
Patient Iron Levels
Iron stores drawn at baseline and every four weeks.
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study start31 Oct 2001
- Primary completion29 Jun 2004
- Study completion29 Jun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, M.D., Principal investigator, UT MDAnderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254436
- Sponsor's protocol ID
- ID00-264
- Status last verified
- Oct 2018
- First submitted
- 14 Nov 2005
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00254436
- Acronym / sponsor ID
- ID00-264
- Conditions
- Gastrointestinal Cancer, Rectal Cancer
- Keywords
- Epoetin Alfa, Epogen, Erythropoietin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Ortho Pharmaceuticals
- Study start
- 31 Oct 2001 (actual)
- Primary completion
- 29 Jun 2004 (actual)
- Study completion
- 29 Jun 2004 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin Alfa | Experimental | Drug: Procrit (epoetin alfa) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procrit (epoetin alfa)Also: Epogen, ErythropoietinWeekly dose | Drug | Epoetin Alfa |
Primary outcome
Number of Patients with Reduction in Red Blood Cell Transfusions
Time frame: 2 years
Patient Iron Levels
Time frame: Every 4 weeks
Iron stores drawn at baseline and every four weeks.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, M.D. principal investigator
UT MDAnderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procrit (epoetin alfa) in people with Gastrointestinal Cancer and Rectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Reduction in Red Blood Cell Transfusions (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.