Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

Status: Active

Description

The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent
  • Locally advanced, unresectable disease, as defined by NCCN criteria
  • ECOG performance status 0-1
  • Age ≥ 18 years
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine >1.5 mg/dL
  • AST and ALT ≤ 3.0 X the upper normal limit of institution's normal range
  • Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range
  • PT and PTT must be ≤ 1.5 X upper normal limit of institution's normal range
  • INR ≤ 1.5
  • Life expectancy > 12 weeks
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day prior to administration of the first dose of chemotherapy
  • Provide written informed consent
  • Subjects willing to participate in the study for at least 8 months

Exclusion Criteria

  • Any prior treatment for pancreatic cancer
  • Any evidence of metastatic disease or another active malignancy within the past two years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
  • Prior biliary bypass surgery
  • Subjects unable or unwilling to have their first randomized treatment within three weeks of the post induction imaging and within five weeks of their last induction treatment
  • Subjects without baseline tumor imaging
  • Stenosis or occlusion in intended artery for treatment that precludes IA therapy as determined by CT or MRI
  • Tortuosity preventing the delivery of the guide sheath and or RenovoCath™ catheter to intended site as determined by CT or MRI
  • Inability to exclude major side branches in the area of the intended RenovoCath™ occlusion as determined by CT or MRI
  • No suitable artery with a diameter greater than 4mm in proximity of at least one side of the tumor as determined by CT or MRI
  • Subjects with known HIV or active viral hepatitis
  • Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
  • Signs or symptoms of infection within 2 weeks prior to the first study treatment
  • Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
  • Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment
  • Subjects with uncontrolled seizures
  • Cardiovascular disease including unstable angina; therapy for life-threatening cardiac arrhythmia, myocardial infarction, stroke; or NYHA Class III or IV congestive heart failure within the last 3 months prior to initiation of study treatment
  • Life-threatening visceral disease or other severe concurrent disease
  • Any major surgery within 4 weeks, minor surgery within 2 weeks or other minor procedures requiring light sedation, such as endoscopies or mediport placement, within 48 hours prior to initiation of study treatment
  • Women who are breastfeeding
  • Male or female subjects of reproductive potential who do not agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after the last study treatment
  • Subjects concurrently receiving any other investigational agents within 2 weeks prior to the first study treatment
  • Any psychiatric illness or social situations that would limit compliance with study requirements

Locations & Contacts

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Peter Muscarella
Email: pmuscare@montefiore.org

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: In review
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: In review
Name Not Available

Trial Objectives and Outline

All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
RenovoRx

Trial IDs

Primary ID RR3 [CP-03-001]
Secondary IDs NCI-2018-01348, RR3
Clinicaltrials.gov ID NCT03257033