Colorectal CancerPhase 2NCT00004195
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
A Phase 2 study testing eniluracil and conventional colon surgery in people with Colorectal Cancer, run by University of Alabama at Birmingham.
Trial summary
RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs. PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- eniluracil and conventional colon surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to May 2001
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
- PATIENT CHARACTERISTICS:A. Age: 19 and over
- Performance status: Karnofsky 60-100%
- Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
- PRIOR CONCURRENT THERAPY:
- Subject has had at least 8 weeks since prior fluorouracil, capecitabine, fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy:
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- No prior or concurrent steroids Radiotherapy:
- Surgery: No prior emergent surgery (e.g., perforation or obstruction) No prior transplantation
- At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase enzyme At least 8 weeks since prior flucytosine
Who cannot join
- Severe infection(White Blood Cell Count)WBC>2 times normal
- Fever
- Sepsis
- Subject on immunosuppressives therapy
- Subjects will serum Bilirubin/Creatinine>2 times normal levels
- Pregnant /Lactating women
- Subjects that have received eniluracil or 5-FU(Fluorouracil) within 28 days prior to randomization
- Subject that have comorbidity illnesses that will increase the likelihood of there death in <5 years
About this study
Official title: Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil
RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs.
PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the enzymatic activity of dihydropyrimidine dehydrogenase (DPD) in peripheral blood mononuclear cells (PBMC), normal mucosa, or normal liver in patients with primary or metastatic colorectal cancer. II. Evaluate the ability of eniluracil to inactivate DPD in the tumor, PBMCs, and normal tissue in this patient population. III. Assess DPD recovery and uracil levels in PBMCs following surgical resection in these patients.
OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to colorectal tumor (primary vs metastatic). Patients are randomized into one of two treatment arms. Arm I: Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0. Arm II: Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0. Patients are followed weekly for 1 month.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- eniluracil, conventional colon surgery
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eniluracilDrug
Also called 5 Fu/eniluracil (eli Lilly), 5-fu/eniluracil, 5fu/eniluraci
Will be given to either subject pre-operative and metastatic disease
conventional colon surgeryProcedure or surgery
Only if the subject is amenable to surgical resections
| Study group | Role | What they receive |
|---|---|---|
| Oral eniluracil 20 mg twice daily | Active comparator | 20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection Receives: Drug: eniluracil; Procedure: conventional colon surgery |
| Placebo | Placebo comparator | 20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection Receives: Drug: eniluracil; Procedure: conventional colon surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Goal to demonstrate that eniluracil at current clinical doses
To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance
Measured: Pre-operative and up to 30 days after first dose
Secondary outcomes (1)
Evaluate DPD recovery and uracil levels
To evaluate the recovery of DPD and uracil levels at 4 more times in the range of postoperative days 5-7,12-16,20-24,and 26-30.
Measured: pre-operative and up to 30 post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2004 (estimated)
- Study startSep 1998
- Primary completionOct 1999
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Glaxo Wellcome
- Responsible party
- Principal investigator, Marty Heslin, University of Alabama at Birmingham
- Investigators
- Martin J. Heslin, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004195
- Sponsor's protocol ID
- CDR0000067438
- Other IDs
- F980826006
- Status last verified
- Jun 2015
- First submitted
- 21 Jan 2000
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil
- ClinicalTrials.gov ID
- NCT00004195
- Acronym / sponsor ID
- CDR0000067438
- Conditions
- Colorectal Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Glaxo Wellcome
- Study start
- Sep 1998
- Primary completion
- Oct 1999 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 16 Sep 2004 (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.
RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs.
PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the enzymatic activity of dihydropyrimidine dehydrogenase (DPD) in peripheral blood mononuclear cells (PBMC), normal mucosa, or normal liver in patients with primary or metastatic colorectal cancer. II. Evaluate the ability of eniluracil to inactivate DPD in the tumor, PBMCs, and normal tissue in this patient population. III. Assess DPD recovery and uracil levels in PBMCs following surgical resection in these patients.
OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to colorectal tumor (primary vs metastatic). Patients are randomized into one of two treatment arms. Arm I: Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0. Arm II: Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0. Patients are followed weekly for 1 month.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral eniluracil 20 mg twice daily | Active comparator | Drug: eniluracil, Procedure: conventional colon surgery20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection |
| Placebo | Placebo comparator | Drug: eniluracil, Procedure: conventional colon surgery20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
- PATIENT CHARACTERISTICS:A. Age: 19 and over
- Performance status: Karnofsky 60-100%
- Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
- PRIOR CONCURRENT THERAPY:
Key exclusion criteria (8 listed)
- Severe infection(White Blood Cell Count)WBC>2 times normal
- Fever
- Sepsis
- Subject on immunosuppressives therapy
- Subjects will serum Bilirubin/Creatinine>2 times normal levels
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 |
|---|---|---|
| eniluracilAlso: 5 Fu/eniluracil (eli Lilly), 5-fu/eniluracil, 5fu/eniluraciWill be given to either subject pre-operative and metastatic disease | Drug | Oral eniluracil 20 mg twice daily, Placebo |
| conventional colon surgeryOnly if the subject is amenable to surgical resections | Procedure or surgery | Oral eniluracil 20 mg twice daily, Placebo |
Primary outcome
Primary Goal to demonstrate that eniluracil at current clinical doses
Time frame: Pre-operative and up to 30 days after first dose
To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance
1 secondary outcome
Evaluate DPD recovery and uracil levels
Time frame: pre-operative and up to 30 post first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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.
Martin J. Heslin, MD study chair
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eniluracil and conventional colon surgery in people with Colorectal Cancer, run by University of Alabama at Birmingham.
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 8 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: finished, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Goal to demonstrate that eniluracil at current clinical doses (time frame: Pre-operative and up to 30 days after first dose). 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 15 Jun 2015.