CancerPhase 2NCT00624312
Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
A Phase 2 study testing Procrit in people with Cancer, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Procrit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2010
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing a major surgical oncology procedure as defined below:
- Pancreatectomy
- Hepatectomy
- Esophagectomy
- Gastrectomy
- Retroperitoneal Sarcoma Resection
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- 18 years of age and older
- Hemoglobin level of ≥ 10g/dL to < 13g/dL, within 10 days of enrollment
- If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- If subject is a sexually active male or a sexually active female of child- bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
- IRB-approved informed consent, signed by the subject or the subject's legally authorized representative ≥ 18 years of age
Who cannot join
- Pre-operative hemoglobin level ≥ 13g/dL or < 10g/dL
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110)
- History of allergy to Procrit®
- Known hypersensitivity to mammalian cell-derived products or human albumin
- History of spontaneous venous thrombotic vascular events
- Anemia due to factors other than cancer,(e.g. iron deficiency, B12 deficiency)
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- History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events. Prior superficial thrombophlebitis is not an exclusion criterion
- History of (within 6 months) uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes Unstable Angina, Q wave Myocardial Infarction (QwMI), and non-Q wave myocardial infarction (NQMI)
- Currently receiving therapeutic or prophylactic anticoagulants for conditions other than planned surgery. The only exceptions are low dose aspirin (≤ 325 mg/day) or low dose anticoagulant to maintain patency of intravenous (IV) lines
- Patient is a candidate for autologous blood transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
- Conditions
- Cancer
- Being tested
- Procrit, Placebo
- Keywords
- Procrit, Erythropoietin, Patients undergoing major surgical oncology operations
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcritDrug
Also called Epoetin Alfa
10 days prior to surgery - injection of 60,000 IU of Procrit
Day of surgery - injection of 60,000 IU of Procrit
PlaceboDrug
10 days prior to surgery - injection with 60,000 IU of placebo
Day of surgery - injection with 60,000 IU of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pre-operatively randomized to Procrit Receives: Drug: Procrit |
| 2 | Placebo comparator | Pre-operatively randomized to placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients receiving transfusion.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624312
- Sponsor's protocol ID
- 07.0048
- Status last verified
- Sep 2013
- First submitted
- 15 Feb 2008
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
- ClinicalTrials.gov ID
- NCT00624312
- Acronym / sponsor ID
- 07.0048
- Conditions
- Cancer
- Keywords
- Procrit, Erythropoietin, Patients undergoing major surgical oncology operations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 27 Feb 2008 (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.
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ProcritPre-operatively randomized to Procrit |
| 2 | Placebo comparator | Drug: PlaceboPre-operatively randomized to placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Undergoing a major surgical oncology procedure as defined below:
- 18 years of age and older
- Hemoglobin level of ≥ 10g/dL to < 13g/dL, within 10 days of enrollment
- If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- If subject is a sexually active male or a sexually active female of child- bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
Key exclusion criteria (10 listed)
- Pre-operative hemoglobin level ≥ 13g/dL or < 10g/dL
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110)
- History of allergy to Procrit®
- Known hypersensitivity to mammalian cell-derived products or human albumin
- History of spontaneous venous thrombotic vascular events
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 |
|---|---|---|
| ProcritAlso: Epoetin Alfa10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit | Drug | 1 |
| Placebo10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo | Drug | 2 |
Primary outcome
Proportion of patients receiving transfusion.
Time frame: One Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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.
Robert Martin, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Procrit in people with Cancer, run by University of Louisville 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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Aug 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients receiving transfusion. (time frame: One Year). 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 6 Aug 2021.