Description:
This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with
FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable,
previously untreated pancreatic adenocarcinoma. The primary objective of this study is to
investigate the safety and feasibility of this treatment regimen in this patient population.
Title
- Brief Title: A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma
- Official Title: A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)
Clinical Trial IDs
- ORG STUDY ID:
UF-STO-PANC-004
- SECONDARY ID:
IRB201800866 -A
- SECONDARY ID:
OCR16281
- NCT ID:
NCT03483038
Conditions
- Pancreatic Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Liposomal Irinotecan | ONIVYDE | Liposomal irinotecan with FOLFOX |
FOLFOX regimen | | Liposomal irinotecan with FOLFOX |
Purpose
This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with
FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable,
previously untreated pancreatic adenocarcinoma. The primary objective of this study is to
investigate the safety and feasibility of this treatment regimen in this patient population.
Trial Arms
Name | Type | Description | Interventions |
---|
Liposomal irinotecan with FOLFOX | Experimental | Subjects will receive 8 cycles and each cycle is 14 days. | - Liposomal Irinotecan
- FOLFOX regimen
|
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age.
- A new clinical diagnosis of resectable or borderline resectable, previously untreated
pancreatic adenocarcinoma confirmed by pathologic specimen evaluation
- No clinical evidence of metastatic disease
- Potentially resectable local disease, as confirmed by CT or MRI of the abdomen
- ECOG performance status of 0 or 1
- Any biliary obstruction must have been treated.
- Subjects with known or suspected Gilbert's disease must be formally tested for
UGT1A1*28 with results available to study team prior to treatment initiation
- Adequate organ function; as defined by:
i. Hematologic-
1. ANC > 1,500 cells/μl without the use of hematopoietic growth factors; and
2. Platelet count > 100,000 cells/μl; and
3. Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with
hemoglobin levels below 9 g/dL)
ii. Hepatic-
1. Serum total bilirubin within normal range for the institution (biliary drainage
is allowed for biliary obstruction),
2. AST and ALT less than or equal to 2.5 x ULN
iii. Renal- Serum creatinine less than or equal to 1.5 x ULN
iv. Cardiac- Normal ECG or ECG without any clinically significant findings as
defined by the treating physician
- Women of childbearing potential must be using an adequate method of contraception to
avoid pregnancy throughout the study and for at least 6 weeks after the last dose of
study drug to minimize the risk of pregnancy
- Males with female partners of child-bearing potential must agree to use
physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)
throughout the study and should avoid conceiving children for 6 weeks following the
last dose of study drug.
Exclusion Criteria:
- A medical history of prior anti-cancer treatment for pancreatic cancer.
- Locally advanced unresectable disease or evidence of metastatic disease.
- Any other invasive malignancy within the past three years.
- Presence of any known contraindications to or hypersensitivities to the
investigational products.
- Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to
study entry.
- A non-surgical candidate.
- Subject is unable to understand, provide consent or comply with study requirements,
treatments or instructions in the opinion of the treating physician.
- Uncontrolled diarrhea, active infection, known interstitial lung disease or other
medical condition that precludes safe administration of this combination therapy
consistent with manufacturer recommendations.
- Unwilling/unable to comply with birth control requirements while on study.
- Females or males of childbearing potential who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for at least 6
weeks after the last dose of study drug.
- Females who are pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of protocol therapy or that might affect the interpretation of
the results of the study or that puts the subject at high risk for treatment
complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up
procedures.
- Known dihydrypyrimidine (DPD) deficiency
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 30 day post operative complication rate |
Time Frame: | 30 days |
Safety Issue: | |
Description: | To determine the 30 day post operative complication rate, as measured by hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay |
Secondary Outcome Measures
Measure: | Treatment Completion Rate |
Time Frame: | 4 months |
Safety Issue: | |
Description: | To determine the treatment completion rate of therapy, as defined by the percentage of subjects that completed all intended cycles |
Measure: | Rate of complete surgical resection |
Time Frame: | 7 months |
Safety Issue: | |
Description: | To determine the rate of complete surgical resection (R0) |
Measure: | Objective Response Rate |
Time Frame: | 5 months |
Safety Issue: | |
Description: | To determine radiographic objective response rate of the primary tumor as measured by RECIST v 1.1 criteria |
Measure: | Biochemical Response Rate |
Time Frame: | 9 months |
Safety Issue: | |
Description: | To determine the biochemical response rate and pattern of response as measured by serial CA 19-9 levels |
Measure: | Patient-Reported Quality of Life |
Time Frame: | 9 months |
Safety Issue: | |
Description: | To determine the patient-reported quality of life during treatment as measured by the NCI validated FACT-G survey |
Measure: | Rate of other pathologic downstaging |
Time Frame: | 7 months |
Safety Issue: | |
Description: | To determine the rate of other pathologic downstaging |
Measure: | To determine the safety of liposomal irinotecan in combination with 5-fluorouracil, oxaliplatin, and leucovorin as assessed by the number of treatment-related adverse events as assessed by CTCAE v 4.0 |
Time Frame: | 9 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Florida |
Trial Keywords
- pancreatic adenocarcinoma
- neoadjuvant
- ONIVYDE
- chemotherapy
- borderline resectable
- resectable
Last Updated
August 25, 2021