Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

NCT05360732 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20-1027GI-170
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (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

  2 months

Secondary Outcomes (4)

• To assess the Progression Free Survival (PFS)

  2 years

• To assess the Overall Survival (OS)

  2 years

• To assess the Objective Response Rate (ORR)

  2 years

• To assess the Delayed Toxicity Rate

  8 weeks

Study Arms (1)

Experimental: FOLFIRINOX

EXPERIMENTAL

FOLFIRINOX: Oxaliplatin, Leucovorin and 5-Fluorouracl, Irinotecan,

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

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

Experimental: FOLFIRINOX

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• \. Endocrine or acinar pancreatic carcinoma
• Patients who have had any systemic chemotherapy in the metastatic or locally advanced inoperable setting (adjuvant or neoadjuvant therapy is allowed)
• Patients who have received radiation therapy within 2 weeks of signing consent.
• Patients who are currently receiving or have previously received any other investigational therapy for metastatic pancreatic cancer.
• 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.
• 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.
• 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.
• Patients with grade 3 or higher baseline sensory neuropathy
• Patients with chronic diarrhea (\>4 bowel movements/day) unresolved despite best supportive care for greater than 2 weeks.
• Patients with any of the following results on the Comprehensive Geriatric Assessment:
• \>2 falls in the past month
• BMI \<18

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 4, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)