Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel Untreated Pancreatic Cancer

NCT04672005 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: Pro2020002395072011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

The main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  The primary objective of this study is to determine time to treatment failure (TTF) in patients with metastatic pancreatic cancer treated in front line setting with mFOLFIRINOX (mFFX) alternating with biweekly Gemcitabine and nab-Paclitaxel (mGnabP).

  24 weeks

Secondary Outcomes (6)

• Response Evaluation Criteria in Solid Tumors (RECIST 1.1

  24 weeks

• Progression-free survival (PFS)

  24 weeks

• Overall survival (OS)

  24 weeks

• Safety and tolerability assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  24 weeks

• EORTC QLQ-CIPN20 questionnaire

  Administered at baseline prior to start of therapy, then every 8 weeks while receiving therapy, and at the end of treatment, average of 1 year

Other Outcomes (1)

• Correlation between variation of ctDNA and progression free survival

  24 weeks

Study Arms (1)

Treatment Regimen: mFOLFIRINOX + mGnabP

EXPERIMENTAL

All study participants will receive the following treatment: mFOLFIRINOX (28-day cycle) Day 1 and Day 15: Oxaliplatin 85 mg/m2 2-hour intravenous infusion followed by leucovorin 400 mg/m2 2-hour infusions with the addition of irinotecan 150 mg/m2 as a 90 minute infusion. 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours will follow irinotecan. Day 3 and Day 17: Pegylated-Granulocyte Colony Stimulating Facotr (peg-GCSF) 6 mg subcutaneous injection following disconnection of 5-FU infusion, first cycle and then per investigator discretion. Biweekly mGnabP (28-day cycle) Day 1 and Day 15: Nab-paclitaxel 125 mg/m2 infused over 30 minutes, immediately followed by Gemcitabine 1200 mg/m2 intravenously infused at the rate of 10mg/m2/min (over 120 minutes). Patients will receive one month of each regimen, alternately monthly until progression of disease.

Drug: Folfirinox alternating with Gemcitabine-nab-Paclitaxel

Interventions

Folfirinox alternating with Gemcitabine-nab-Paclitaxel DRUG

modified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel

Also known as: Oxaliplatin, Leucovorin, Irinotecan, Nab-Paclitaxel, Gemcitabine

Treatment Regimen: mFOLFIRINOX + mGnabP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically confirmed pancreatic adenocarcinoma.
• Stage IV disease. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data.
• Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received prior neoadjuvant or adjuvant chemotherapy, tumor recurrence must have occurred more than 6 months after completing the last dose of chemotherapy.
• ECOG performance status of 0-1.
• At least 18 years of age.
• Evidence of measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
• Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male and female patients must agree to use effective barrier contraception during the period of therapy.
• Adequate bone marrow function:
• a. ANC ≥ 1500/uL 8b.platelet count ≥ 100,000/uL 8c. hemoglobin ≥ 9.0 g/dL 9. Adequate hepatic function: 9a. Total bilirubin ≤ 1.5 X ULN 9b. AST (SGOT) ≤ 5 X ULN 9c. ALT (SGPT) ≤ 5 X ULN Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
• \. Adequate renal function, Creatinine \< 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
• \. Partial thromboplastin time (PTT) \< 1.2 x ULN and INR ≤ 1.5 x ULN, if not receiving anticoagulation therapy. For patients receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use.
• \. Subject must have no clinically significant abnormalities in urinalysis results (obtained ≤ 14 days prior to starting Cycle 1 Day 1).
• \. Ability to understand the nature of this study protocol and give written informed consent. 14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• Patients who meet any one of the following criteria will be excluded from this study.
• Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas.
• Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
• Presence of central nervous system metastases.
• Life expectancy \< 12 weeks.
• Pregnancy (positive pregnancy test) or lactation.
• Pre-existing sensory neuropathy \> grade 1.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
• Major surgery without complete recovery in the past 4 weeks prior to screening.
• Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
• Concurrent active infection.
• Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C.
• Patient who has a history of allergy or hypersensitivity to any of the study drugs.
• Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Sponsors & Collaborators

• Lyudmyla Berim: lead

Study Sites (7)

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

Location

RWJBarnabas Health - Jersey City Medical Center, Jersey City

Jersey City, New Jersey, 07302, United States

Location

RWJBarnabas Health - Saint Barnabas Medical Center, Livingston

Livingston, New Jersey, 07039, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Leucovorin; Irinotecan; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lyudmyla Berim, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: single group assignment

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 17, 2020
• Study Start: January 6, 2021
• Primary Completion: September 30, 2024
• Study Completion: June 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)