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Antimetabolites

Combination Chemotherapy for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Jill Lacy, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No significant cardiac disease

No history of chronic diarrhea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they can shrink a pancreatic tumor before surgery and kill any remaining cells after surgery.

Who is the study for?

This trial is for patients with localized pancreatic cancer who haven't had previous treatments. They should be able to undergo surgery, have no other cancers or major health issues like heart disease, uncontrolled seizures, serious lung fibrosis, or severe nerve damage in the hands and feet. Participants need good organ function and an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory).Check my eligibility

What is being tested?

The study tests a combination of chemotherapy drugs (leucovorin calcium, fluorouracil, irinotecan hydrochloride, oxaliplatin) given before and after surgery to see if they can shrink pancreatic tumors pre-surgery and eliminate remaining cancer cells post-surgery.See study design

What are the potential side effects?

Chemotherapy may cause side effects such as nausea, vomiting, diarrhea, fatigue, mouth sores, low blood cell counts leading to increased infection risk or bleeding problems. There's also a chance of nerve damage that could result in tingling or numbness in the hands and feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have serious heart problems.

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I do not have a history of chronic diarrhea.

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I do not have any other type of cancer.

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I am fully active or can carry out light work.

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I do not have lung fibrosis or pneumonia.

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I do not have uncontrolled seizures, active brain diseases, or known brain disorders.

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My diagnosis of pancreatic cancer is confirmed by lab tests.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival rate

Secondary outcome measures

Objective response rate

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mFOLFIRINOX)Experimental Treatment6 Interventions

NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection. ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

FDA approved

Fluorouracil

FDA approved

therapeutic conventional surgery

2003

Completed Phase 3

~12270

Leucovorin

FDA approved

Irinotecan

FDA approved

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,482 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,107 Total Patients Enrolled

Jill Lacy, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Fluorouracil (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02047474 — Phase 2

Pancreatic Cancer Research Study Groups: Treatment (mFOLFIRINOX)

Pancreatic Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT02047474 — Phase 2

Fluorouracil (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02047474 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence is there to suggest that leucovorin calcium does not pose a risk to human health?

"Due to the Phase 2 status of leucovorin calcium, our team at Power has rated its safety on a scale from 1-3 as a two. This means that while there is some data evidencing its security, no clinical evidence suggests efficacy."

Answered by AI

At what facilities is this clinical experiment being conducted?

"Currently, the study is recruiting out of 9 different medical sites situated in Guilford, Fairfield and North Haven among other regions. It is best to select a clinic near you so as to reduce travel demands should you decide to join the trial."

Answered by AI

Are there precedents of research into the effects of leucovorin calcium?

"Currently, 643 live clinical trials for leucovorin calcium are being conducted with 201 of these at Phase 3. Numerous medical centers in Guangzhou, Guangdong have started the trial process but there is a total of 27590 locations operating trials around the world."

Answered by AI

What therapeutic purposes does leucovorin calcium typically treat?

"Leucovorin calcium is frequently employed to treat rectal carcinoma and other malignancies such as ovarian cancer, sarcoma, and colorectal carcinoma."

Answered by AI

How many individuals have enrolled in this clinical research?

"Unfortunately, this trial is no longer inviting participants. Originally posted on March 25th 2014, the listing was last updated October 31st 2022; however, there are presently 1250 trials actively enrolling acinar cell adenocarcinoma of the pancreas patients and 643 studies for leucovorin calcium that are recruiting."

Answered by AI

Does this research study still accept participants?

"This experiment is no longer enrolling patients. Initially posted on March 25th 2014, the most recent alteration occurred October 31st 2022. There are presently 1250 clinical trials actively seeking participants with acinar cell adenocarcinoma of the pancreas and 643 studies for leucovorin calcium currently recruiting volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer

2014. "Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02047474.

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