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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

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival rate

Secondary study objectives

Overall survival

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

~12900