NCT05360732

Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRINOX	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

Timeline

• Start date: 2022-04-22
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-05-04
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study