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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
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
Time frame: 2 months
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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
Time frame: 8 weeks
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