Your session is about to expire
← Back to Search
Antimetabolite Chemotherapy
Chemotherapy Combination for Cancer (I-FLOAT Trial)
Phase 1
Recruiting
Led By Daniel Catenacci, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =1
Age greater than or equal to 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
I-FLOAT Trial Summary
This trial will test if it's safe to combine different chemotherapies to see if they work better together than alone.
Who is the study for?
This trial is for adults with certain advanced gastrointestinal cancers who have a life expectancy over 3 months, good organ function, and no severe neuropathy or uncontrolled bleeding. They must not be pregnant or breastfeeding, haven't had major surgery recently, and can't have had prior chemotherapy for metastatic disease.Check my eligibility
What is being tested?
The I-FLOAT study tests the safety of combining multiple chemotherapies: Irinotecan with 5-Fluorouracil (5-FU), Leucovorin (a vitamin to enhance 5-FU's effect), Oxaliplatin, and Docetaxel in patients with specific types of gastrointestinal cancers.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion like chills or fever; blood cell count changes leading to increased infection risk; fatigue; digestive issues such as nausea, vomiting, diarrhea; liver enzyme alterations; nerve damage that could cause numbness or tingling.
I-FLOAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do light work but not heavy physical activities.
Select...
I am 18 years old or older.
Select...
My jaundice from a tumor was treated and I have a metal biliary stent.
I-FLOAT Trial 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
The maximum dose tolerated
Secondary outcome measures
Cumulative dose of each chemotherapy drug
Overall Response Rate
Overall survival rate
+2 moreSide 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%
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
I-FLOAT Trial Design
3Treatment groups
Experimental Treatment
Group I: Low Risk UGT1A1 genotypeExperimental Treatment5 Interventions
Group II: Intermediate Risk UGT1A1 genotypeExperimental Treatment5 Interventions
Group III: High Risk UGT1A1 genotypeExperimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Docetaxel
FDA approved
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,796 Total Patients Enrolled
12 Trials studying Adenocarcinoma
605 Patients Enrolled for Adenocarcinoma
Daniel Catenacci, MDPrincipal InvestigatorUniversity of Chicago Medicine
4 Previous Clinical Trials
1,129 Total Patients Enrolled
2 Trials studying Adenocarcinoma
83 Patients Enrolled for Adenocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts and liver/kidney functions are within the required ranges.I have had radiation therapy for cancer before.I have not had major surgery in the last 4 weeks.I have experienced mild to severe diarrhea.I am willing to change my current medications to avoid interactions with irinotecan.My cancer can be either visible on scans or not.I am currently experiencing uncontrolled bleeding.I experience significant numbness or pain due to nerve damage.I do not have severe health or mental conditions that would make treatment risky.I have brain metastases confirmed by tests.I can do light work but not heavy physical activities.I am 18 years old or older.I had chemotherapy for metastatic disease less than 6 months before my current treatment.I am taking pancreatic enzyme replacements due to my pancreatic cancer.I have a confirmed advanced or spreading cancer in my digestive system.My jaundice from a tumor was treated and I have a metal biliary stent.I have inflammatory bowel disease (Crohn's or ulcerative colitis).I have had cancer before, but it was either skin cancer treated successfully, cervical cancer that did not spread, or another type with a low risk of coming back.
Research Study Groups:
This trial has the following groups:- Group 1: Low Risk UGT1A1 genotype
- Group 2: High Risk UGT1A1 genotype
- Group 3: Intermediate Risk UGT1A1 genotype
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 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
Could you provide information about any prior experiments with Irinotecan?
"Presently, there are 901 ongoing studies for Irinotecan with 303 trials in their last phase. Most of these tests take place within Guangzhou, Guangdong; however, a total of 47864 sites worldwide are running clinical trials involving this medication."
Answered by AI
Is enrollment in this clinical experiment still available?
"Affirmative. According to the clinicaltrials.gov information, this study is presently open for recruitment - first posted on 8th May 2020 and last updated 7th June 2021. 54 participants are sought from one medical centre."
Answered by AI
What is the total enrollment count for this clinical research?
"Affirmative, clinicaltrials.gov indicates that this trial is in its active recruitment phase. The study was initially posted on May 8th 2020 and last amended on June 7th 2021; 54 participants are needed at 1 medical centre for the venture to proceed."
Answered by AI
What risks could be associated with administering Irinotecan?
"With limited data regarding Irinotecan's efficacy and safety, it received a rating of 1 on our team at Power's scale."
Answered by AI
What medical conditions has Irinotecan been shown to help with?
"Irinotecan is typically used to manage actinic keratosis, but it also has an indication for soft tissue sarcoma (STS), macrocytic anemia, and various malignant neoplasms."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger