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

NCT03257033 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: RR3 [CP-03-001]
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 42

Brief Summary

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Wilcoxin Test

  Up to Five Years

Secondary Outcomes (8)

• Overall Survival for treatment received and unresected populations

  Up to Five Years

• Progression Free Survival

  Up to Five Years

• Objective response rate and duration of response

  Up to Five Years

• Health Related Quality of Life

  Up to Five Years

• Neuropathy Assessment

  1 Year

Study Arms (2)

IA Therapy

EXPERIMENTAL

IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.

Drug: Gemcitabine; Device: RenovoCath

IV Therapy

ACTIVE COMPARATOR

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.

Drug: Gemcitabine; Drug: nab-paclitaxel

Interventions

Gemcitabine DRUG

Chemotherapy

Also known as: Gemzar

IA Therapy; IV Therapy

nab-paclitaxel DRUG

Chemotherapy

Also known as: Abraxane

IV Therapy

RenovoCath DEVICE

Intra-arterial catheter

IA Therapy

Eligibility Criteria

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

You may qualify if:

• Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 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)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Age ≥ 18 years
• 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.
• Absolute neutrophil count (ANC) ≥ 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
• \*Aspartate transaminase (AST) and alanine transaminase (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 -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)
• 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
• 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
• Life expectancy \> 12 weeks
• 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

You may not qualify if:

• 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.
• 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
• Subjects without baseline tumor imaging
• 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:
• Stenosis or occlusion in the intended artery for treatment
• Inability to exclude major side branches in the area of the intended RenovoCath® catheter occlusion
• No suitable artery with a diameter greater than 3 mm in proximity of at least one side of the tumor
• 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
• Contraindications for SBRT planning which includes the following:
• Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy
• 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.
• Subjects with known HIV infection or active viral hepatitis
• 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
• Signs or symptoms of infection within 2 weeks prior to the first study treatment, as assessed by the Investigator

Sponsors & Collaborators

• RenovoRx: lead

Study Sites (42)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

TERMINATED

Sutter Cancer Center Sacramento

Sacramento, California, 95816, United States

RECRUITING

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

WITHDRAWN

Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC

Englewood, Colorado, 80113, United States

WITHDRAWN

Sibley Memorial Hospital - a member of Johns Hopkins medicine

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20057, United States

WITHDRAWN

21st Century Oncology

Fort Myers, Florida, 33907, United States

TERMINATED

Miami Cancer Center

Miami, Florida, 33167, United States

RECRUITING

Sarasota Memorial Health Care System

Sarasota, Florida, 34329, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

TERMINATED

ASCLEPES Research Centers

Weeki Wachee, Florida, 34607, United States

TERMINATED

Piedmont-Columbus Regional - John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

WITHDRAWN

University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

WITHDRAWN

LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

WITHDRAWN

Medstar Franklin Square

Baltimore, Maryland, 21237, United States

TERMINATED

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

TERMINATED

MD Anderson Cancer Center at Cooper Hospital

Camden, New Jersey, 08103, United States

TERMINATED

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, 07960, United States

WITHDRAWN

Albany Stratton VA Medical Center

Albany, New York, 12208, United States

WITHDRAWN

Feinstein Institutes for Medical Research - Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Montefiore Hospital

The Bronx, New York, 10461, United States

TERMINATED

Levine Cancer Institute - Atrium Health

Charlotte, North Carolina, 28204, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

ACTIVE NOT RECRUITING

Oklahoma University - Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, 29425, United States

ACTIVE NOT RECRUITING

Prisma Health (formerly Greenville Health System)

Greenville, South Carolina, 29605, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

WITHDRAWN

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

WITHDRAWN

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

RECRUITING

AZ Sint-Lucas

Bruges, 8310, Belgium

TERMINATED

UZ Antwerp

Edegem, 2650, Belgium

TERMINATED

AZ Maria Middelares

Ghent, 9000, Belgium

TERMINATED

UZ Gent

Ghent, 9000, Belgium

WITHDRAWN

Jolimont Hospital

La Louvière, 7100, Belgium

TERMINATED

AZ Delta

Roeselare, 8800, Belgium

TERMINATED

Related Publications (1)

• 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.

  PMID: 38508449 DERIVED

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael J Pishvaian

  Johns Hopkins Kimmel Cancer Center

  STUDY CHAIR

Central Study Contacts

Nicki Keller

CONTACT

616-516-1162; tigerpac-clinical@renovorx.com

Leesa Gentry

CONTACT

lgentry@renovorx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects with stable or responding disease after approximately four months of induction therapy, and who are not surgical candidates will then be randomized to be in either the test group or control group. Crossovers are not allowed.

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: March 12, 2018
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

BE (6); US (36)