Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
NCT ID: NCT03257033
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
190 participants
INTERVENTIONAL
2018-03-12
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IA Therapy
IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.
Gemcitabine
Chemotherapy
RenovoCath
Intra-arterial catheter
IV Therapy
IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.
Gemcitabine
Chemotherapy
nab-paclitaxel
Chemotherapy
Interventions
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Gemcitabine
Chemotherapy
nab-paclitaxel
Chemotherapy
RenovoCath
Intra-arterial catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the start of cycle 1)
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
4. Age ≥ 18 years
5. Adequate laboratory values prior to receiving the first dose of nab-paclitaxel and gemcitabine: (criterion must be met prior to cycle 2.) For a subject with elevated bilirubin, AST or ALT, who has had a biliary stent placed, if the subject's lab values have returned to within the required range for eligibility noted below in sub-criteria e and f \[(AST) ALT ≤ 3.0 X the upper normal limit, and total bilirubin ≤ 1.5 X the upper normal limit\] after placement of stent and prior to cycle 2, he/she is eligible for the study. Additional details regarding eligibility for subjects who have had biliary stents recently placed are outlined in sub-criteria f and h below.
1. Absolute neutrophil count (ANC) ≥ 1,500/μL
2. Platelet count ≥ 100,000/μL
3. Hemoglobin ≥ 9.0 g/dL
4. Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine \>1.5 mg/dL
5. \*Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 X the upper normal limit of institution's normal range
6. \*Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range -OR- If biliary stent is placed or planned to be placed within 6 weeks of Cycle 1 Day 1 (C1D1), total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range (see section 9.1.4 for dose modification due to elevated bilirubin)
7. Prothrombin time (PT) and partial thromboplastin time (PTT) must be ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion
8. International normalized ration (INR) ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion \*For elevated AST, ALT, and total bilirubin at screening, subject must have a normalized result prior to initiation of Cycle 2 if abnormal labs are considered related to bile duct obstruction and a biliary stent has been placed
6. Life expectancy \> 12 weeks
7. Negative pregnancy test for women of childbearing potential (either serum or urine) within one day prior to administration of the first dose of chemotherapy. Women of childbearing potential should use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation
8. Provide written informed consent
9. Subjects willing to participate in the study for at least 8 months if randomized to IA gemcitabine OR IV gemcitabine + nab-paclitaxel
Exclusion Criteria
2. Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
3. Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment
4. Subjects without baseline tumor imaging
5. As determined by the Sponsor:
Arterial anatomy unsuitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined and approved by the Sponsor Imaging Advisor, which includes the following:
1. Stenosis or occlusion in the intended artery for treatment
2. Inability to exclude major side branches in the area of the intended RenovoCath® catheter occlusion
3. No suitable artery with a diameter greater than 3 mm in proximity of at least one side of the tumor
4. Superior mesenteric vein (SMV) occlusion or stenosis that cannot be resolved with medication or intervention prior to randomization, if the superior mesenteric artery (SMA) is the only viable treatment artery Note: Arterial Anatomy will be reviewed by the Sponsor, RenovoRx Imaging Advisor, and RenovoRx Medical Monitor for approval
6. Contraindications for SBRT planning which includes the following:
1. Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy
2. Prior abdominal radiotherapy judged to have clinically significant degree of overlap with planned SBRT dose distribution Note: Primary tumors with a diameter greater than 7 cm must be assessed on a case-by-case basis with the RenovoRx Imaging Advisor prior to excluding the subject from the trial.
7. Subjects with known HIV infection or active viral hepatitis
8. Severe infections requiring hospitalization within 4 weeks prior to the first study treatment, including but not limited to complications of infection, bacteremia or severe pneumonia
9. Signs or symptoms of infection within 2 weeks prior to the first study treatment, as assessed by the Investigator
10. Received antibiotics for treatment of an infection within 48 hours prior to initiation of study treatment. Subjects receiving prophylactic antibiotics are eligible
11. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
12. Any anti-cancer therapy including chemotherapy, hormonal therapy for prostate cancer, 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
13. Subjects with uncontrolled seizures
14. Cardiovascular disease including unstable angina or life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction (MI), congestive heart failure (CHF), coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction (EF) to ensure EF is not ≤ 40% (as determined by MRI, ECHO, or Nuclear Scan), within the last 3 months prior to the initiation of study treatment
15. Other severe concurrent disease or comorbidities which make it difficult to participate in this study, as assessed by Investigator
16. Any of the following procedures prior to initiation of study treatment:
1. Catheterization, endoscopy, stent or drain placement within 48 hours. (Diagnostic laparoscopy without surgical intervention and/or port placement do not require any wait time prior to study treatment)
2. Minor surgery requiring light sedation (such as surgical laparoscopy) within 2 weeks
3. Major surgery within 4 weeks
17. Women who are breastfeeding
18. Male or female subjects of reproductive potential who do not agree to either remain abstinent or employ highly effective and acceptable forms of contraception throughout their participation in the study and for 6 months after the last study treatment
19. Subjects receiving any other investigational agents within 2 weeks prior to the initiation of treatment
20. Any social situations or psychiatric illness that would limit compliance with study requirements
21. Subjects unable or unwilling to have standard catheterization procedure
18 Years
ALL
No
Sponsors
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RenovoRx
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J Pishvaian
Role: STUDY_CHAIR
Johns Hopkins Kimmel Cancer Center
Locations
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VA Loma Linda Healthcare System
Loma Linda, California, United States
Sutter Cancer Center Sacramento
Sacramento, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC
Englewood, Colorado, United States
Sibley Memorial Hospital - a member of Johns Hopkins medicine
Washington D.C., District of Columbia, United States
Georgetown University
Washington D.C., District of Columbia, United States
21st Century Oncology
Fort Myers, Florida, United States
Miami Cancer Center
Miami, Florida, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
ASCLEPES Research Centers
Weeki Wachee, Florida, United States
Piedmont-Columbus Regional - John B. Amos Cancer Center
Columbus, Georgia, United States
University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
LSU Health Shreveport
Shreveport, Louisiana, United States
Medstar Franklin Square
Baltimore, Maryland, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
MD Anderson Cancer Center at Cooper Hospital
Camden, New Jersey, United States
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States
Albany Stratton VA Medical Center
Albany, New York, United States
Feinstein Institutes for Medical Research - Northwell Health
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Hospital
The Bronx, New York, United States
Levine Cancer Institute - Atrium Health
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Oklahoma University - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States
Prisma Health (formerly Greenville Health System)
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
AZ Sint-Lucas
Bruges, , Belgium
UZ Antwerp
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
UZ Gent
Ghent, , Belgium
Jolimont Hospital
La Louvière, , Belgium
AZ Delta
Roeselare, , Belgium
Countries
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Central Contacts
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References
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Farsad K, Novelli PM, Laing C, Gandhi RT, Cynamon J, Lopez CS, Stempinski ES, Strasser R, Agah R. Double-Balloon Catheter-Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies. J Vasc Interv Radiol. 2024 Jul;35(7):1043-1048.e3. doi: 10.1016/j.jvir.2024.03.016. Epub 2024 Mar 18.
Other Identifiers
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RR3 [CP-03-001]
Identifier Type: -
Identifier Source: org_study_id