Colon CancerPhase 2NCT02138617
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
A Phase 2 study testing 5-Fluorouracil, Leucovorin and Irinotecan in people with Colon Cancer, run by UNC Lineberger Comprehensive Cancer Center at 7 sites in United States.
Trial summary
This study involves standard combination chemotherapy treatment for colon cancer, 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- 5-Fluorouracil, Leucovorin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 May 2014to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must meet all of the inclusion criteria to participate in this study:
- An Institutional Review Board-approved informed consent obtained and signed
- Age ≥ 18 years
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Measurable or non-measurable (but evaluable) disease as defined via RECIST 1.1
- Metastatic disease not amenable to surgical resection with curative intent
Show all 19Show fewer
- No prior chemotherapy for metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see section 11.1, Appendix A)
- Adequate bone marrow, renal and hepatic function, as evidenced by the following:
- absolute neutrophil count (ANC) ≥1,500/mm3
- platelets ≥100,000/mm3
- hemoglobin ≥9.0 g/dL
- serum creatinine ≤1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤3x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer
- Bilirubin ≤1.5 X ULN
- Alkaline phosphatase ≤3 x ULN (≤5 x ULN with liver involvement of their cancer)
- Willing to undergo UGT1A1 genotyping
- Negative pregnancy test (urine or serum), within 7 day prior to Day 1 of FOLFIRI in women of childbearing potential
- Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
Who cannot join
- UGT1A1 genotype other than *1/*1, *1/*28, or *28/*28
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Prior treatment with irinotecan and/or bevacizumab
- Unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 14 days (fruits and juices for at least 7 days) prior to Day 1 of FOLFIRI + bevacizumab initiation (see section 11.2, Appendix B, for list of prohibited drugs)
- Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- Prior history of hypertensive encephalopathy
Show all 21Show fewer
- Active cardiac disease including any of the following:
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see section 11.3, Appendix C)
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1 of FOLFIRI + bevacizumab initiation
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of FOLFIRI + bevacizumab initiation
- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of FOLFIRI + bevacizumab initiation
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of FOLFIRI + bevacizumab initiation or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of FOLFIRI + bevacizumab initiation
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of FOLFIRI + bevacizumab initiation
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by:
- Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
- Any serious uncontrolled medical disorder that would impair the ability of the subject to receive protocol-driven therapy
- Other anti-cancer or investigational therapy while patients are on study therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Carolina Healthcare Systems
Charlotte, North Carolina, 28204
Cone Health Cancer Center
Greensboro, North Carolina, 27403
IU Simon Cancer Center
Indianapolis, Indiana, 46202
IU Arnett Hospital
Lafayette, Indiana, 47905
Bon Secours Cancer Institute
Midlothian, Virginia, 23114
Rex Healthcare
Raleigh, North Carolina, 27607
About this study
Official title: Genotype-Directed Phase II Study Of Higher Dose Of Irinotecan In First-Line Metastatic Colorectal Cancer Patients Treated With Folfiri Plus Bevacizumab
This study involves standard combination chemotherapy treatment for colon cancer, 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes". Genes are made of DNA and determine not only inherited traits or appearance (hair and eye color, height, body type, etc.) but also play an important role in health and how the body responds to illness and treatments for those illnesses.
In this study, the investigators will examine the relationship between a patient's genes (DNA), or "genotype", and how the patient's body breaks down and removes or "metabolizes" the anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important role in how well this drug works against a patient's cancer as well as the adverse side effects the patient may experience. The current standard dose of irinotecan was determined in clinical trials without knowing individual genotypes and thus does not take into account a patient's ability to metabolize irinotecan. This means that based on one genotype the current standard dose of irinotecan may be correct or based on other genotypes the standard dose could result in lower and possibly less effective blood levels and result in significant under-dosing of irinotecan.
Read more
Based on genotype the patient will be assigned to one of the following doses of irinotecan:
- 180 mg/m2 (standard dose)
- 260 mg/m2
- 310 mg/m2
The purpose of this research study is to determine if dosing irinotecan based on genotype is effective and safe for patients with colon cancer. Patient genotype will be determined from a small sample of blood and a laboratory test or "assay" performed at University of North Carolina Laboratories. For the purpose of this study, this assay is new and considered to be "investigational". This means that the genotype assay used in this study has not yet been approved by the FDA for determining irinotecan dose levels in patients with colon cancer.
Read the detailed description
This phase II multicenter clinical trial will use a genotype-guided dosing strategy for irinotecan to prospectively analyze efficacy in 100 metastatic colorectal cancer patients (mCRC) receiving FOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) plus bevacizumab. Irinotecan is detoxified and excreted primarily by glucuronidation in the liver via the isoenzyme uridine diphosphate glucuronosyl transferase (UGT1A1). Common variants in UGT1A1 alter the rate of glucuronidation and thus alter exposure to irinotecan.
The UGT1A1 *28 allele results in slower irinotecan glucuronidation, and thus greater exposure to its active metabolite SN-38. At the standard irinotecan dose used in FOLFIRI (180 mg/m2; established prior to our understanding of the importance of genotype in the rate of this drug's metabolism), there is a small increased risk of neutropenia in *28 homozygotes. However, the risk of clinically important consequences of neutropenia, such as febrile neutropenia and infection, are not significantly increased. Patients with other genotypes have a quite low risk of adverse effects suggesting patients with these low risk genotypes may tolerate higher doses of irinotecan in FOLFIRI. This finding was demonstrated in a phase I study in which *1/*28 and *1/*1 genotypes were able to tolerate escalating doses of irinotecan up to 260 mg/m2 and 310 mg/m2, respectively.
The central hypothesis of this trial is that increasing the irinotecan dose in *1/*28 and *1/*1 genotypes will increase the overall benefit of FOLFIRI for patients with mCRC as these two groups are likely under-dosed with the current dosing regimen. Eligible patients will be genotyped for UGT1A1 and assigned into 1 of 3 different dosing groups, based on their relative rate of metabolism. The primary objective of this trial is to estimate progression-free survival (PFS), and secondary objectives include characterization of toxicity and objective response rate (OR; complete response (CR) + partial response (PR)).
- Conditions
- Colon Cancer
- Being tested
- 5-Fluorouracil, Leucovorin, Irinotecan, Bevacizumab
- Keywords
- Colon Cancer, Irinotecan, FOLFIRI, Genotyping, UGT1A1
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
Also called 5-FU, Adrucil
400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours, Day 1 and Day 15 .
LeucovorinDrug
Also called LV, leucovorin calcium, folinic acid, citrovorum factor
200-400 mg/m2 IV over 2 hours, Day 1 and Day 15
IrinotecanDrug
Also called Camptosar, Novaplus Irinotecan Hydrochloride
IV infusion over 90 minutes, dosed at 180, 260 or 310 mg/m2 based on genotype.
BevacizumabDrug
Also called Avastin, MVASI
Bevacizumab (5 mg/kg IV infused as per institutional policy, IV, Day 1, 15)
| Study group | Role | What they receive |
|---|---|---|
| *1/*1 Genotype | Experimental | FOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 310 mg/m2,(IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab |
| *1/*28 Genotype | Experimental | FOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 260 mg/m2, FOLFIRI (IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab |
| *28/*28 | Experimental | FOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 180 mg/m2, FOLFIRI (IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression-free Free Survival is defined as the time from day 1 (D1) of treatment to progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST)1.1 or death from any cause. Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of registration until date of first documented progression up to 8 years.
Secondary outcomes (3)
Number of Participants With Grade 3 or Higher Adverse Events
The toxicity profile when irinotecan is dosed according to isoenzyme uridine diphosphate glucuronosyl transferase (UGT1A1) Genotypes was evaluated and Grade 3 or higher adverse events were reported. Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
Measured: From date of registration up to 8 years.
Overall Response
Overall Response (OR =Complete Response +Partial Response) will be defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 5 years
Overall Survival Rate
The Overall Survival rate (OS) is defined as the percentage of participants alive after time from D1 of treatment to death from any cause.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start6 May 2014
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Hanna Sannoff, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138617
- Sponsor's protocol ID
- LCCC1317
- Status last verified
- Apr 2025
- First submitted
- 1 May 2014
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype-Directed Phase II Study Of Higher Dose Of Irinotecan In First-Line Metastatic Colorectal Cancer Patients Treated With Folfiri Plus Bevacizumab
- ClinicalTrials.gov ID
- NCT02138617
- Acronym / sponsor ID
- LCCC1317
- Conditions
- Colon Cancer
- Keywords
- Colon Cancer, Irinotecan, FOLFIRI, Genotyping, UGT1A1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University Cancer Research Fund
- Study start
- 6 May 2014 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves standard combination chemotherapy treatment for colon cancer, 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes". Genes are made of DNA and determine not only inherited traits or appearance (hair and eye color, height, body type, etc.) but also play an important role in health and how the body responds to illness and treatments for those illnesses.
In this study, the investigators will examine the relationship between a patient's genes (DNA), or "genotype", and how the patient's body breaks down and removes or "metabolizes" the anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important role in how well this drug works against a patient's cancer as well as the adverse side effects the patient may experience. The current standard dose of irinotecan was determined in clinical trials without knowing individual genotypes and thus does not take into account a patient's ability to metabolize irinotecan. This means that based on one genotype the current standard dose of irinotecan may be correct or based on other genotypes the standard dose could result in lower and possibly less effective blood levels and result in significant under-dosing of irinotecan.
Based on genotype the patient will be assigned to one of the following doses of irinotecan:
- 180 mg/m2 (standard dose)
- 260 mg/m2
- 310 mg/m2
The purpose of this research study is to determine if dosing irinotecan based on genotype is effective and safe for patients with colon cancer. Patient genotype will be determined from a small sample of blood and a laboratory test or "assay" performed at University of North Carolina Laboratories. For the purpose of this study, this assay is new and considered to be "investigational". This means that the genotype assay used in this study has not yet been approved by the FDA for determining irinotecan dose levels in patients with colon cancer.
Detailed description
This phase II multicenter clinical trial will use a genotype-guided dosing strategy for irinotecan to prospectively analyze efficacy in 100 metastatic colorectal cancer patients (mCRC) receiving FOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) plus bevacizumab. Irinotecan is detoxified and excreted primarily by glucuronidation in the liver via the isoenzyme uridine diphosphate glucuronosyl transferase (UGT1A1). Common variants in UGT1A1 alter the rate of glucuronidation and thus alter exposure to irinotecan.
The UGT1A1 *28 allele results in slower irinotecan glucuronidation, and thus greater exposure to its active metabolite SN-38. At the standard irinotecan dose used in FOLFIRI (180 mg/m2; established prior to our understanding of the importance of genotype in the rate of this drug's metabolism), there is a small increased risk of neutropenia in *28 homozygotes. However, the risk of clinically important consequences of neutropenia, such as febrile neutropenia and infection, are not significantly increased. Patients with other genotypes have a quite low risk of adverse effects suggesting patients with these low risk genotypes may tolerate higher doses of irinotecan in FOLFIRI. This finding was demonstrated in a phase I study in which *1/*28 and *1/*1 genotypes were able to tolerate escalating doses of irinotecan up to 260 mg/m2 and 310 mg/m2, respectively.
The central hypothesis of this trial is that increasing the irinotecan dose in *1/*28 and *1/*1 genotypes will increase the overall benefit of FOLFIRI for patients with mCRC as these two groups are likely under-dosed with the current dosing regimen. Eligible patients will be genotyped for UGT1A1 and assigned into 1 of 3 different dosing groups, based on their relative rate of metabolism. The primary objective of this trial is to estimate progression-free survival (PFS), and secondary objectives include characterization of toxicity and objective response rate (OR; complete response (CR) + partial response (PR)).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| *1/*1 Genotype | Experimental | Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Irinotecan, Drug: BevacizumabFOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 310 mg/m2,(IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. |
| *1/*28 Genotype | Experimental | Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Irinotecan, Drug: BevacizumabFOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 260 mg/m2, FOLFIRI (IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. |
| *28/*28 | Experimental | Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Irinotecan, Drug: BevacizumabFOLFIRI (5-fluorouracil (5-FU), leucovorin, irinotecan) Irinotecan dose 180 mg/m2, FOLFIRI (IV, Day 1, 15); Bevacizumab (IV, Day 1, 15), repeat treatment cycle every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- An Institutional Review Board-approved informed consent obtained and signed
- Age ≥ 18 years
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Measurable or non-measurable (but evaluable) disease as defined via RECIST 1.1
- Metastatic disease not amenable to surgical resection with curative intent
Key exclusion criteria (21 listed)
- UGT1A1 genotype other than *1/*1, *1/*28, or *28/*28
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Prior treatment with irinotecan and/or bevacizumab
- Unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 14 days (fruits and juices for at least 7 days) prior to Day 1 of FOLFIRI + bevacizumab initiation (see section 11.2, Appendix B, for list of prohibited drugs)
- Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
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 |
|---|---|---|
| 5-FluorouracilAlso: 5-FU, Adrucil400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours, Day 1 and Day 15 . | Drug | *1/*1 Genotype, *1/*28 Genotype, *28/*28 |
| LeucovorinAlso: LV, leucovorin calcium, folinic acid, citrovorum factor200-400 mg/m2 IV over 2 hours, Day 1 and Day 15 | Drug | *1/*1 Genotype, *1/*28 Genotype, *28/*28 |
| IrinotecanAlso: Camptosar, Novaplus Irinotecan HydrochlorideIV infusion over 90 minutes, dosed at 180, 260 or 310 mg/m2 based on genotype. | Drug | *1/*1 Genotype, *1/*28 Genotype, *28/*28 |
| BevacizumabAlso: Avastin, MVASIBevacizumab (5 mg/kg IV infused as per institutional policy, IV, Day 1, 15) | Drug | *1/*1 Genotype, *1/*28 Genotype, *28/*28 |
Primary outcome
Progression Free Survival
Time frame: From date of registration until date of first documented progression up to 8 years.
Progression-free Free Survival is defined as the time from day 1 (D1) of treatment to progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST)1.1 or death from any cause. Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
Number of Participants With Grade 3 or Higher Adverse Events
Time frame: From date of registration up to 8 years.
Overall Response
Time frame: 5 years
Overall Survival Rate
Time frame: 8 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lineberger Comprehensive Cancer Center websiteLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Hanna Sannoff, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Fluorouracil, Leucovorin and Irinotecan in people with Colon Cancer, run by UNC Lineberger Comprehensive Cancer Center at 7 sites 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 19 inclusion and 21 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: From date of registration until date of first documented progression up to 8 years.). 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 18 May 2025.