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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT02782182

Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study

A Phase 1 study testing FOLFIRINOX (oxaliplatin, leucovorin, irinotecan) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
28 Jun 2016to 29 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
  • Resectable primary tumor of the head, body or tail of the pancreas defined per NCCN Guidelines version 2.2015:
  • No extra-pancreatic disease, aside from lymphadenopathy
  • No arterial tumor contact (celiac axis, superior mesenteric artery, or common hepatic artery)
  • No tumor contact with the superior mesenteric vein or portal vein or ≤ 180° contact without vein contour irregularity
  • Confirmation of resectability by surgical oncology consultation.
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  • No previous therapy for pancreatic cancer
  • Short removable metal stents rather than plastic stents are strongly encouraged but not required for palliation of initial obstructive jaundice
  • ECOG performance status of 0 or 1 (Appendix 1)
  • Age > 18 years
  • No CVA within 6 months, no MI within 6 months
  • The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Negative pregnancy test in females of reproductive age
  • Anticoagulation is permitted but patients may not be on warfarin.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin < 1.5X upper limits of normal
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance >60 mL/min/ per Cockroft-Gault equation for patients with creatinine levels above institutional normal.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
  • Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
  • Patients who are receiving any investigational agents.
  • Patients with borderline resectable, locally advanced or metastatic disease.
  • History of allergic reactions attributed to 5-FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements.
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  • Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mFOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years.
  • Pre-existing neuropathy greater than grade 1.
  • Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn's disease, ulcerative colitis).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.

Read the detailed description

Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection.

Secondary Objectives

  • To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy.
  • To assess treatment-related toxicity during preoperative therapy
  • To assess intra-operative and post-operative complications
  • To assess the histopathologic (R0/R1) resection rate after preoperative therapy
  • To determine disease free survival (DFS) for patients who undergo resection.
  • To determine progression free survival (PFS) for all patients
  • To determine overall survival (OS) from the date of first treatment
Being tested
FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)
Keywords
Pancreatic ductal adenocarcinoma, FOLFIRINOX, resectable pancreatic cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)Drug

    FOLFIRINOX administered preoperatively and postoperatively

Study groups in NCT02782182
Study groupRoleWhat they receive
FOLFIRINOX+surgeryExperimental4 cycles of pre-operative FOLFIRINOX, followed by surgery, followed by 2 more cycles of FOLFIRINOX
Receives: Drug: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection

    Measured by percentage of successes/failures

    Measured: 4 months

Secondary outcomes (7)

  1. The extent of preoperative chemotherapy, surgery, and adjuvant chemotherapy.

    Reported as a yes/no for each element of therapy.

    Measured: 6 months

  2. Presence of adverse events

    Presence of grade 3 and 4 toxicities measured according to NCI CTCAE version 4.0.

    Measured: 6 months

  3. Intraoperative and post-op complications

    Any unexpected events as determined by surgical oncologist

    Measured: Within 6 weeks post surgery

  4. R0/R1 resection rates

    Measured as proportion of patients with microscopic negative and microscopic residual tumor margin

    Measured: 6 months

  5. Disease free survival

    Defined by date from surgical resection to radiographic recurrence or death

    Measured: Up to 5 years

  6. Progression free survival

    Defined by radiographic progression by RECIST criteria or death

    Measured: Up to 5 years

  7. Overall survival

    Defined by date from Cycle 1 Day 1 of preoperative chemotherapy to death from any cause.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study start28 Jun 2016
  3. Primary completion29 Mar 2018
  4. Study completion29 Mar 2018

Why it stopped: Closed early due to poor accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02782182
Sponsor's protocol ID
IRB15-1630
Status last verified
Mar 2019
First submitted
16 May 2016
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FOLFIRINOX (oxaliplatin, leucovorin, irinotecan) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Closed early due to poor accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02782182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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