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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
Must not have
Prior radiation therapy for any cancer
Diarrhea grade 1 or greater by NCI-CTCAE, v. 4.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do light work but not heavy physical activities.
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I am 18 years old or older.
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My jaundice from a tumor was treated and I have a metal biliary stent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy for cancer before.
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I have experienced mild to severe diarrhea.
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I am currently experiencing uncontrolled bleeding.
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I experience significant numbness or pain due to nerve damage.
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I do not have severe health or mental conditions that would make treatment risky.
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I have brain metastases confirmed by tests.
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I am taking pancreatic enzyme replacements due to my pancreatic cancer.
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I have inflammatory bowel disease (Crohn's or ulcerative colitis).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The maximum dose tolerated
Secondary study objectives
Cumulative dose of each chemotherapy drug
Overall Response Rate
Overall survival rate
+2 more

Side effects data

From 2020 Phase 2 & 3 trial • 483 Patients • NCT03098030
66%
Anaemia
51%
Neutropenia
28%
Asthenia
26%
Decreased appetite
26%
Neutrophil count decreased
25%
Nausea
25%
Thrombocytopenia
20%
Platelet count decreased
18%
Fatigue
16%
White blood cell count decreased
15%
Diarrhoea
15%
Pyrexia
15%
Constipation
15%
Dyspnoea
14%
Leukopenia
11%
Alopecia
10%
Hyperglycaemia
10%
Abdominal pain
10%
Cough
10%
Pneumonia
9%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
7%
Stomatitis
7%
Vomiting
7%
Back pain
7%
Anemia
7%
Dizziness
6%
Non-cardiac chest pain
6%
Lymphocyte count decreased
6%
Abdominal pain upper
6%
Blood alkaline phosphatase increased
6%
Blood lactate dehydrogenase increased
6%
Hypotension
5%
Hypokalaemia
5%
Hypomagnesaemia
5%
Headache
5%
Arthralgia
5%
Febrile neutropenia
3%
Productive cough
3%
Muscular weakness
3%
Pain in extremity
3%
Bronchitis
3%
Musculoskeletal chest pain
3%
Hypertension
2%
Small cell lung cancer
2%
Chronic obstructive pulmonary disease
2%
Neck pain
2%
Myalgia
2%
Confusional state
2%
Anxiety
2%
Upper respiratory tract infection
2%
Musculoskeletal pain
2%
Pleural effusion
2%
Haemoglobin decreased
2%
Hyponatraemia
2%
Pulmonary embolism
1%
Hypocalcaemia
1%
Dysphonia
1%
Respiratory tract infection
1%
Hypertriglyceridaemia
1%
Diarrhea
1%
Rash
1%
Klebsiella sepsis
1%
Blood creatinine increased
1%
Dyskinesia
1%
Hypoxia
1%
Dehydration
1%
Acute coronary syndrome
1%
Cardiac failure
1%
Febrile bone marrow aplasia
1%
Ejection fraction decreased
1%
Epistaxis
1%
Pyelonephritis
1%
Atrial flutter
1%
Dry mouth
1%
Acute kidney injury
1%
Death
1%
Acute myocardial infarction
1%
Supraventricular tachycardia
1%
Gastrooesophageal reflux disease
1%
Neutropenic colitis
1%
Herpes zoster
1%
Pain
1%
Hypercholesterolaemia
1%
Leukocytosis
1%
Troponin I increased
1%
Chest pain
1%
Pleuritic pain
1%
Malignant pleural effusion
1%
Metastases to central nervous system
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Topotecan
Part 2: Dinutuximab + Irinotecan
Part 1: Dinutuximab + Irinotecan
Part 2: Irinotecan

Awards & Highlights

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.

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
1,062 Previous Clinical Trials
840,080 Total Patients Enrolled
Daniel Catenacci, MDPrincipal InvestigatorUniversity of Chicago Medicine
4 Previous Clinical Trials
1,083 Total Patients Enrolled

Media Library

5-Fluorouracil (Antimetabolite Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04361708 — Phase 1
Cancer Research Study Groups: Low Risk UGT1A1 genotype, High Risk UGT1A1 genotype, Intermediate Risk UGT1A1 genotype
Cancer Clinical Trial 2023: 5-Fluorouracil Highlights & Side Effects. Trial Name: NCT04361708 — Phase 1
5-Fluorouracil (Antimetabolite Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04361708 — Phase 1
~4 spots leftby Jun 2025
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