RECRUITING

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

Conditions

Pancreatic Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1 Dose Finding Study of the gFOLFOXIRITAX Regimen Using UGT1A1 Genotype-directed Irinotecan With Fluorouracil, Leucovorin, Oxaliplatin and Taxotere in Patients With Untreated Advanced Upper Gastrointestinal Adenocarcinomas: The I-FLOAT Study

Quick Facts

Study Start:2020-05-08

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04361708

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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.

Inclusion Criteria

Exclusion 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:
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.

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.

Contacts and Locations

Study Contact

Daniel Catenacci, MD

CONTACT

773-702-7596

dcatenacci@medicine.bsd.uchicago.edu

Principal Investigator

Daniel Catenacci, MD

PRINCIPAL_INVESTIGATOR

University of Chicago Medicine

Study Locations (Sites)

The University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Daniel Catenacci, MD, PRINCIPAL_INVESTIGATOR, University of Chicago Medicine

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

Study Start Date2020-05-08

Study Completion Date2027-05

Study Record Updates

Study Start Date2020-05-08

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Adenocarcinoma