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Metastatic Pancreatic CancerPhase 2NCT05360732

Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

A Phase 2 study testing FOLFIRINOX in people with Metastatic Pancreatic Cancer, run by Fox Chase Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi- centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
FOLFIRINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65 years or older
  • The treating physician will use their discretion when assessing if the patient is eligible for this treatment.
  • Patients must have newly diagnosed and previously untreated, histologically or cytologically confirmed adenocarcinoma of the pancreas, with at least one site of metastatic disease (local recurrences after surgery allowed), with lesions that are measurable by RECIST v1.1 criteria. In patients with mixed histology tumors, the predominant feature must be adenocarcinoma.
  • Eastern Cooperative Oncology Group Performance status of 0-2.
  • Previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to signing consent and adjuvant therapy was administered more than 6 months prior to signing consent.
  • Patients must have bone marrow and organ function as defined below:
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  • Absolute Neutrophil Count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Total Bilirubin ≤2 X ULN
  • AST(SGOT)/ALT(SGPT)/
  • o Alkaline Phasphatase ≤3 X ULN
  • o Or ≤5x ULN if liver metastasis present
  • Creatinine ≤2.0 mg/dL And
  • eGFR (using Cockcroft Gault equation) > 40ml/min
  • Patients must be fluent in English and must be able and willing to undergo Comprehensive Geriatric Assessment
  • Chemotherapy is harmful to the human fetus. For this reason, sexually active males with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
  • Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
  • Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.

Who cannot join

  • 1. Endocrine or acinar pancreatic carcinoma
  • 2 Patients who have had any systemic chemotherapy in the metastatic or locally advanced inoperable setting (adjuvant or neoadjuvant therapy is allowed)
  • 3 Patients who have received radiation therapy within 2 weeks of signing consent.
  • 4 Patients who are currently receiving or have previously received any other investigational therapy for metastatic pancreatic cancer.
  • 5 Patients with known brain metastases - treated or untreated, are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events.
  • 6 Any patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known active or inactive hepatitis B, untreated HCV or treated HCV without a documented sustained virologic response are excluded from the study.
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  • 7 Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • 8 Patients with evidence of active malignancy within 2 years of enrollment without definitive treatment. Patients with localized prostate cancer status-post surgical resection or definitive radiation, localized ER/PR+/HER2- breast cancer status-post definitive local treatment with a low OncotypeDx® on adjuvant hormonal therapy, or local skin cancers that were previously resected will be eligible for inclusion. Patients with a history of in situ cancers treated with definitive local therapy will also be eligible.
  • 9 Patients with grade 3 or higher baseline sensory neuropathy
  • 10 Patients with chronic diarrhea (>4 bowel movements/day) unresolved despite best supportive care for greater than 2 weeks.
  • 11 Patients with any of the following results on the Comprehensive Geriatric Assessment:
  • >2 falls in the past month
  • BMI <18

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Redefining The Use Of A FOLFIRINOX-Like Regimen In the Front Line In Older Patients With Metastatic Pancreatic Cancer

This is a multi- centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years.

Read the detailed description

This is a multi-centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years. Treatment will be given in the outpatient infusion room or clinical research unit. Reported adverse events and potential risks of these agents are described below. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.

The study will accrue 37 patients who will be evaluated by correlating their daily activity via use of FitBit that will be provided to the patients, blood markers and progression of the disease with the toxicity grades observed during the treatment. Patients will be treated with standard of care doses of all the chemotherapeutic drugs. The study will be analyzed for futility after treatment of 20 patients. Each cycle consists of 28 days during which patient treatment will alternate between FOLFOX and FOLFIRI on day 1 and day 14 respectively. Patients will be treated until disease progression or any of the conditions listed in Section 4.4 that applies. Patient's response to treatment will be evaluated by CT scans every 8 weeks and the tumor will be assessed using RECIST v1.1 criteria.

Being tested
FOLFIRINOX
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • FOLFIRINOXDrug

    Alternating FOLFOX and FOLFIRI administered via intravenous infusion. FOLFOX: Oxaliplatin 85 mg/m2 on Day 1; Leucovorin 400 mg/m2 on day 1; 5-FU: 400 mg/m2 IV push on Day 1 followed by 2400 mg/m2 continuous infusion over 46-48 hours. FOLFIRI: Irinotecan 180 mg/m2 on day 1, leucovorin 400 mg/m2, 5-FU: 400 mg/m2 IV push on Day 1 followed by 2400 mg/m2 continuous infusion over 46-48 hours

Study groups in NCT05360732
Study groupRoleWhat they receive
Experimental: FOLFIRINOXExperimentalFOLFIRINOX: Oxaliplatin, Leucovorin and 5-Fluorouracl, Irinotecan,
Receives: Drug: FOLFIRINOX

What is being measured

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

  1. To assess the toxicity profile of a regimen of alternating FOLFOX and FOLFIRI patients assessed as per NCI's CTCAE v5.0 criteria.

    To assess the toxicity profile of a regimen of alternating FOLFOX and FOLFIRI at 2 months in newly diagnosed and untreated metastatic pancreatic adenocarcinoma patients over the age of 65 years deemed ineligible to receive the FOLFIRINOX regimen

    Measured: 2 months

Secondary outcomes (4)

  1. To assess the Progression Free Survival (PFS)

    To assess the Progression Free Survival (PFS) defined as the time from enrollment to disease progression, death or last patient contact, whichever comes first, for up to 2 years from the end of treatment visit.

    Measured: 2 years

  2. To assess the Overall Survival (OS)

    Overall Survival (OS) is defined as the time from treatment initiation to death due to any cause or overall survival. Patients will be followed for up to 2 years after the end of treatment visit.

    Measured: 2 years

  3. To assess the Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the best response in terms of tumor shrinkage measured by RECIST v1.1 criteria obtained during protocol therapy.

    Measured: 2 years

  4. To assess the Delayed Toxicity Rate

    Delayed Toxicity Rate is defined as the absolute percentage of toxicities as measured according toNCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 8 weeks

Timeline

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

  1. First posted4 May 2022
  2. Study start22 Apr 2022
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360732
Sponsor's protocol ID
20-1027
Other IDs
GI-170
Status last verified
Oct 2026
First submitted
14 Apr 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRINOX in people with Metastatic Pancreatic Cancer, run by Fox Chase Cancer Center 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 18 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

To assess the toxicity profile of a regimen of alternating FOLFOX and FOLFIRI patients assessed as per NCI's CTCAE v5.0 criteria. (time frame: 2 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 NCT05360732.

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 29 Oct 2026.

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