Trial Title:
A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID:
NCT05851924
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Capecitabine
Conditions: Keywords:
NALIRIFOX
Ablative Dose Radiation
23-027
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This study is a single-arm, phase II study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NALIRIFOX
Description:
Patients will receive NALIRIFOX for a total of 4 months. NALIRIFOX will be administered
on days 1 and 15 of a 4-week cycle for 4 cycles until completion of therapy, intolerable
toxicity, or until the development of criteria for removal from the study.
Liposomal irinotecan: 50 mg/m2 IV over the course of 90 minutes (±10 minutes) on days 1
and 15 of every 4-week cycle.
Oxaliplatin: 60 mg/m2 IV over the course of 120 minutes (±10 minutes) on days 1 and 15 of
every 4-week cycle.
Leucovorin: 400 mg/m2 IV over the course of 30 minutes (±5 minutes) on days 1 and 15 of
every 4-week cycle.
5-FU: 2400 mg/m2 IV over the course of 48 hours (or until the infusion is complete) on
days 1 and 15 of every 4-week cycle
Arm group label:
NALIRIFOX + AD-XRT and capecitabine
Intervention type:
Combination Product
Intervention name:
AD-XRT and Capecitabine
Description:
The interval between completion of induction chemotherapy and initiation of AD-XRT will
be 2-6 weeks. The patient will be concurrently treated with capecitabine (1000-1500 mg
flat BID PO Monday to Friday) with radiation, as per standard dosing regimens at MSK.
Arm group label:
NALIRIFOX + AD-XRT and capecitabine
Summary:
The researchers are doing this study to find out whether using the chemotherapy regimen
NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard
chemotherapy drug capecitabine is an effective treatment approach for people with locally
advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery.
This type of treatment approach is called total neoadjuvant therapy (TNT). The
researchers will also look at whether the sequence of the treatment approach (NALIRIFOX +
ADXRT and capecitabine followed by surgery, when it is possible) is effective and causes
few or mild side effects in participants. An important purpose of the study is to see how
the study treatment (NALIRIFOX + AD-XRT and capecitabine) affects participants' quality
of life. The researchers will measure quality of life by having participants fill out
questionnaires
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject has been informed about the nature of the study, has agreed to participate
in the study, and has signed the informed consent form before participation in any
study-related activities.
2. Individuals with a history of other malignancies are eligible if they have been
disease-free for at least 2 years and are deemed by the investigator to be at low
risk for recurrence of that malignancy.
Individuals with the following cancers are eligible if diagnosed and treated within
the past 5 years: cervical cancer in situ, DCIS, stage I prostate cancer, and basal
cell or squamous cell carcinoma of the skin.
3. A multidisciplinary discussion has been undertaken/planned which can include (a)
discussion with medical/surgery oncology, (b) Hepatopancreaticobiliary Disease
Management Team conference presentation, (c) direct consultation, with confirmation
on consensus plan for TNT strategy and potential for future surgery. This plan needs
to be documented in the medical record prior to initiation of treatment.
4. Male or nonpregnant and nonlactating female aged ≥18 years.
1. Women of child-bearing potential (i.e., fertile, following menarche, and until
becoming postmenopausal unless permanently sterile; permanent sterilization
methods include hysterectomy, bilateral salpingectomy, and bilateral
oophorectomy) must test negative for pregnancy at the time of screening on the
basis of a urine or serum pregnancy test. Postmenopausal women are defined as
those who have had an absence of menstruation for at least 2 years. If
necessary, follicle-stimulating hormone results >50 IU/L at screening are
confirmatory in the absence of a clear postmenopausal history.
2. Female subjects of reproductive potential must agree to use two effective
methods of birth control during the study and for 9 months after the last dose
of study medication.
3. Male subjects must agree to use condoms during the study and for 4 months after
the last dose of study medication'
Disease-specific inclusion criteria:
1. Histologically or cytologically confirmed PDAC that has not been previously treated.
2. Radiographically BR or LA PDAC in accordance with the NCCN 2.2021 definition,
without evidence of distant metastases by CT.
3. Inoperable status after surgical exploration due to presence of locally advanced,
unresectable disease without metastases, in patients who have recovered from
surgery, is allowed.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Hematological, biochemical, and organ function inclusion criteria:
1. Absolute neutrophil count (ANC) ≥1500/mm^3 without the use of hemopoietic
growth factors within 7 days before treatment
2. Platelet count ≥100,000/mm^3 .
3. International normalized ratio (INR) <1.5 unless the patient is receiving
anticoagulation therapy, in which case a therapeutic INR is acceptable.
Anticoagulation therapy with low-molecularweight heparin or warfarin, whether
medically indicated, is permitted.
4. Adequate renal function, as evidenced by serum/plasma creatinine level <1.6
mg/dL
Exclusion Criteria:
1. Presence of metastatic pancreatic cancer (M1 disease)
2. Any other medical or social condition deemed by the investigator to be likely to
interfere with a subject's ability to sign informed consent, cooperate, and
participate in the study or who is likely to interfere with the interpretation of
the results.
3. Unwilling or unable to comply with study procedures and/or study visits.
4. Medical co-morbidities, that preclude major abdominal surgery
5. Histologic diagnosis other than adenocarcinoma; however, adenosquamous variants are
acceptable.
6. Receipt of chemotherapy, prior abdominal radiotherapy, and/or definitive resection
for pancreatic cancer.
7. Grade >2 neuropathy.
8. Pregnant and/or nursing.
9. Uncontrolled active infection, which would preclude with the exception of resolving
cholangitis which in the investigator opinion would render the treatment hazardous.
10. Known hypersensitivity to any of the components of the chemotherapeutic agents
11. Receipt of concurrent investigational therapy or within 30 days of protocol
initiation.
Additional criterion for the immunoPET imaging sub-study (n=20)
12. Previous anaphylactic reaction to human, humanized or chimeric antibody.
13. Refusal or inability to tolerate the scanning procedure (e.g. due to
claustrophobia).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Facility:
Name:
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Contact backup:
Last name:
Eileen O'Reilly, MD
Phone:
646-888-4182
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alice Wei, MD
Phone:
212-639-5643
Start date:
May 12, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Ipsen
Agency class:
Industry
Collaborator:
Agency:
Pancreatic Cancer Research Fund
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851924
http://www.mskcc.org/mskcc/html/44.cfm
