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Alkylating agents

Genotype-Directed Chemotherapy for Colorectal Cancer

Phase 2
Waitlist Available
Led By Hanna Sannoff, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic disease not amenable to surgical resection with curative intent
Willing to undergo UGT1A1 genotyping
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights

Study Summary

This trial is testing a new way to give colon cancer patients a standard combination chemotherapy treatment, which includes the anti-cancer drugs 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus the anti-angiogenesis drug bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes".

Who is the study for?
Adults with measurable metastatic colorectal cancer who haven't had chemotherapy for it yet. They must be in fairly good health, willing to have their UGT1A1 gene tested, and able to use effective birth control. People can't join if they have certain heart conditions, uncontrolled high blood pressure, severe proteinuria, recent major surgeries or injuries, a history of significant bleeding disorders or stroke within the past 6 months.Check my eligibility
What is being tested?
The trial is testing different doses of irinotecan (180 mg/m2, 260 mg/m2, or 310 mg/m2) combined with standard chemo drugs (5FU and leucovorin) plus bevacizumab for colon cancer treatment. The dose depends on the patient's genotype which affects how well they process the drug. This could make treatment more effective and safer.See study design
What are the potential side effects?
Possible side effects include diarrhea from irinotecan; mouth sores, low blood counts from 5FU; nerve damage from leucovorin; and hypertension or increased risk of bleeding from bevacizumab. Side effects vary based on individual reactions to these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread and cannot be removed by surgery to cure it.
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I am willing to have a genetic test for UGT1A1.
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My blood, kidney, and liver tests are within normal ranges.
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My alkaline phosphatase levels are within the normal range.
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I agree to use birth control during the study.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My cancer is confirmed to be adenocarcinoma of the colon or rectum.
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I have signed the consent form approved by the ethics committee.
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I haven't had chemotherapy for cancer that has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Number of Participants with adverse events
Overall Response
Overall Survival

Side effects data

From 2016 Phase 4 trial • 128 Patients • NCT01588990
68%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Insomnia
20%
Paraesthesia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Infective exacerbation of chronic obstructive airways disease
1%
Inguinal hernia
1%
Colitis
1%
Colonic obstruction
1%
Muscle abscess
1%
Infected dermal cyst
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B

Trial Design

3Treatment groups
Experimental Treatment
Group I: *28/*28Experimental Treatment4 Interventions
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.
Group II: *1/*28 GenotypeExperimental Treatment4 Interventions
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.
Group III: *1/*1 GenotypeExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Fluorouracil
2012
Completed Phase 3
~7800
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,232 Total Patients Enrolled
Hanna Sannoff, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

Irinotecan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02138617 — Phase 2
Colon Cancer Research Study Groups: *1/*1 Genotype, *28/*28, *1/*28 Genotype
Colon Cancer Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT02138617 — Phase 2
Irinotecan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02138617 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical centers is this research study being conducted today?

"This trial has 7 enrolling sites, with Cone Health Cancer Center in Greensboro, University of North carolina in Chapel Hill, and IU Arnett Hospital in Lafayette being 3 of them."

Answered by AI

Are there other ongoing medical studies that are using Irinotecan?

"At this time, 834 clinical trials are underway to study the efficacy of Irinotecan. Of these 226 live trials, the majority (202) are in Phase 3. Most of these Shanghai-based trials are taking place in China (39489 locations), but there are other global sites as well."

Answered by AI

Are there any vacancies in this clinical trial for new participants?

"This study is not recruiting at the moment, however it was last updated on 6/7/2022. There are a total of 834 trials for Irinotecan and 257 clinical trials for malignant neoplasm of colon currently enrolling patients if you're interested in other studies."

Answered by AI

Has the FDA sanctioned Irinotecan for public use?

"There is some clinical data supporting the safety of Irinotecan, but none for efficacy. As such, it was given a score of 2."

Answered by AI

What are the standard conditions that Irinotecan helps to improve?

"While rectal carcinoma is the most common reason to use Irinotecan, this medication can also be helpful for patients with colorectal carcinoma, sarcoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many people are taking part in this research?

"As of right now, this particular trial is not looking for new patients. However, there are a total of 834 clinical trials enrolling Irinotecan participants and 257 studies seeking patients with malignant neoplasm of the colon."

Answered by AI

Who else is applying?

What site did they apply to?
Carolina Healthcare Systems
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
2014. "Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02138617.
All > Colon Cancer > Cte
~24 spots leftby Jun 2027
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