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Anti-cancer drug
Genotype-Guided Irinotecan for Colorectal and Pancreatic Cancer
N/A
Recruiting
Led By Reema A Patel, MD
Research Sponsored by Reema A. Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 1
Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare two treatments for pancreas and colorectal cancer, one based on a patient's genotype and the other on usual care.
Who is the study for?
This trial is for adults over 18 with stage I-IV pancreatic or stage III-IV colorectal cancer who are about to start treatment. They must have a certain UGT1A1 gene type, good organ function, and an ECOG performance status of ≤1. Pregnant women, those not planned for treatment, previous irinotecan users, or patients with uncontrolled illnesses that could affect therapy adherence cannot join.Check my eligibility
What is being tested?
The GENOCARE trial is testing whether adjusting the dose of Irinotecan based on the patient's specific genotype (UGT1A1) leads to better outcomes than usual care in treating pancreatic and colorectal cancers. Participants will be randomly assigned to either receive genotype-guided dosing or standard treatment.See study design
What are the potential side effects?
Irinotecan can cause side effects like diarrhea, low white blood cell counts (increasing infection risk), fatigue, hair loss, nausea and vomiting. The severity can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I have been diagnosed with stage I-IV pancreatic or stage III-IV colorectal cancer and am planning treatment.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events Frequency
Secondary outcome measures
Overall Survival
Side effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
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%
Paraesthesia
20%
Insomnia
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%
Fall
8%
Anxiety
8%
Dry skin
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Dehydration
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%
Anal fissure
1%
Infective exacerbation of chronic obstructive airways disease
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Clostridium difficile colitis
1%
Infected dermal cyst
1%
Colonic obstruction
1%
Inguinal hernia
1%
Muscle abscess
1%
Ileus
1%
Gastroenteritis viral
1%
Colitis
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Genocare GuidedExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Find a Location
Who is running the clinical trial?
Reema A. PatelLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
Reema A Patel, MDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that my doctor thinks could interfere with the treatment.I am fully active and can carry on all pre-disease activities without restriction.I have had surgery or radiation, but no treatments with irinotecan.My cancer can be measured by tests or scans.I am not scheduled for any cancer treatment.My organs and bone marrow are functioning well.I have been diagnosed with stage I-IV pancreatic or stage III-IV colorectal cancer and am planning treatment.I am 18 years old or older.I have never been treated with irinotecan.
Research Study Groups:
This trial has the following groups:- Group 1: Genocare Guided
- Group 2: Usual Care
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this trial?
"Affirmative. Clinicaltrials.gov reveals that this research project, which began recruiting on September 28th 2022, is still active and in search of participants. 178 individuals are needed from a single medical site for the trial to progress."
Answered by AI
How many individuals are being recruited for this experiment?
"Affirmative. On clinicaltrials.gov, it is indicated that this medical trial commenced recruitment on 28th September 2022 and was last adjusted 13th October of the same year. This research requires 178 volunteers to be enrolled at one healthcare facility."
Answered by AI
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