$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies

2020-05-08

2025-06

2027-05

54

Study Overview

Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies

The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).

N/A

  • Pancreatic Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Adenocarcinoma
  • DRUG: Oxaliplatin
  • DRUG: Docetaxel
  • DRUG: Leucovorin
  • DRUG: Irinotecan
  • DRUG: 5-Fluorouracil
  • IRB19-1292

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-04-22  

N/A  

2024-09-06  

2020-04-23  

N/A  

2024-09-19  

2020-04-24  

N/A  

2024-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: High Risk UGT1A1 genotype

DRUG: Oxaliplatin

  • Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Docetaxel

  • Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4

DRUG: Leucovorin

  • Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Irinotecan

  • Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2

DRUG: 5-Fluorouracil

  • 5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.
EXPERIMENTAL: Intermediate Risk UGT1A1 genotype

DRUG: Oxaliplatin

  • Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Docetaxel

  • Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4

DRUG: Leucovorin

  • Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Irinotecan

  • Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2

DRUG: 5-Fluorouracil

  • 5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.
EXPERIMENTAL: Low Risk UGT1A1 genotype

DRUG: Oxaliplatin

  • Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Docetaxel

  • Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4

DRUG: Leucovorin

  • Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)

DRUG: Irinotecan

  • Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2

DRUG: 5-Fluorouracil

  • 5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.
Primary Outcome MeasuresMeasure DescriptionTime Frame
The maximum dose toleratedTo determine the maximum tolerated dose in the first month of therapy in each of the three main genotype groups (low, intermediate, and high risk) using genotype-guided dosing of irinotecan as part of the I-FLOAT regimen1 month
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Cumulative dose of each chemotherapy drugTo determine the cumulative dose of each chemotherapy drug (irinotecan, 5-FU, oxaliplatin, docetaxel) administered in each genotype group over a period of 4 months (8 doses).4 months
Total duration of therapyTo determine the total duration of therapy, which would be administered perioperatively in future studies for the curative-intent setting.18 months
Overall Response RateTo determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.5 years
Progression free survival rateTo determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.5 years
Overall survival rateTo determine early efficacy (overall responsive rate, progression free survival, and overall survival) in all patients enrolled and treated in the study.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daniel Catenacci, MD

Phone Number: 773-702-7596

Email: dcatenacci@medicine.bsd.uchicago.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with upper GI primary suspected), or other primary GI malignancy for which the treating physician feels that I-FLOAT is a reasonable therapeutic option. 2. Patients with a history of obstructive jaundice due to the primary tumor must have resolved to <1.5 X upper limit of normal and a metal biliary stent in place 3. Age greater than or equal to 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status =1 5. Life expectancy > 3 months 6. Adequate organ function, as defined by each of the following:
    Absolute neutrophil count (ANC) = 1500/uL Hemoglobin > 9g/dL (transfusion permitted with stability for > 1 week) Platelets > 100,000/uL Total bilirubin = 1.5 mg/dL AST and ALT = 2.5 X upper limit of normal; alkaline phosphatase = 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis.
    AST and ALT = 5 X upper limit of normal if hepatic metastases are present. Creatinine = 1.5 mg/dL 7. Measurable or non-measurable disease will be allowed. 8. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. 9. Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential 10. Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan.
    Exclusion Criteria:
    1. Prior radiation therapy for any cancer. 2. Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met 3. Inflammatory bowel disease (Crohn's disease, ulcerative colitis) 4. Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v. 4.0*). Pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement. 5. Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0. 6. Documented brain metastases 7. Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment. 8. Active uncontrolled bleeding. 9. Pregnancy or breastfeeding. 10. Major surgery within 4 weeks. 11. Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%, and meets all other eligibility criteria.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Daniel Catenacci, MD, University of Chicago Medicine

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate