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Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC (TIGeR-PaC)

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ClinicalTrials.gov Identifier: NCT03257033
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
RenovoRx

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

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Drug: Gemcitabine Drug: nab-paclitaxel Device: RenovoCath Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Gemcitabine
Chemotherapy
Other Name: Gemzar

Device: RenovoCath
Intra-arterial catheter
Other Name: RenovoCath RC120

Active Comparator: 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.
Drug: Gemcitabine
Chemotherapy
Other Name: Gemzar

Drug: nab-paclitaxel
Chemotherapy
Other Name: Abraxane




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 Years ]
    OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Log-Rank Test


Secondary Outcome Measures :
  1. Overall Survival for treatment received and unresected populations [ Time Frame: 3 Years ]
    The primary endpoint analysis will be repeated for the Treatment Received and Unresected Subject populations.

  2. Progression Free Survival [ Time Frame: 3 Years ]
    To compare the Progression Free Survival of intra-arterial delivery of gemcitabine using the RenovoCath™ device vs. continuation of IV gemcitabine and nab-paclitaxel following induction therapy with gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Disease response and progression will be assessed according to RECIST 1.1.

  3. Objective response rate and duration of response [ Time Frame: 3 Years ]
    Objective response is defined as a complete response, CR, or partial response, PR, determined by Investigator assessment and confirmed by repeat assessment ≥ 4 weeks after initial documentation.

  4. Health Related Quality of Life [ Time Frame: 3 Years ]
    The EORTC questionnaire will be used to assess health related quality of life. The summary scores for the EORTC questionnaire will be calculated at baseline and follow-up.

  5. Neuropathy Assessment [ Time Frame: 1 Year ]
    The degree of neuropathy will be measured by the FACT/GOG-NTX-4 (version 4). The results will be cross tabulated by randomized treatment group for each study visit.

  6. Frequency of neutropenia [ Time Frame: 1 Year ]
    Neutropenia with onset after randomization requiring the use of filgrastim or other medications for white blood cell stimulation will be compared between the test and control groups through progression of disease.

  7. Patient reported symptoms [ Time Frame: 3 years ]
    Symptoms reported by subjects using the PRO-CTCAE questionnaire will be compared between the test and control groups through progression of disease.

  8. Safety, defined as adverse event rate, and tolerability, defined as occurrence of treatment discontinuation [ Time Frame: 3 years ]
    Safety and tolerability will be assessed by the occurrence of treatment discontinuation and the presence of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent
  2. Locally advanced, unresectable disease, as defined by NCCN criteria
  3. ECOG performance status 0-1
  4. Age ≥ 18 years
  5. Absolute neutrophil count ≥ 1,500/μL
  6. Platelet count ≥ 100,000/μL
  7. Hemoglobin ≥ 9.0 g/dL
  8. Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine >1.5 mg/dL
  9. AST and ALT ≤ 3.0 X the upper normal limit of institution's normal range
  10. Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range
  11. PT and PTT must be ≤ 1.5 X upper normal limit of institution's normal range
  12. INR ≤ 1.5
  13. Life expectancy > 12 weeks
  14. 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
  15. Provide written informed consent
  16. Subjects willing to participate in the study for at least 8 months

Exclusion Criteria:

  1. Any prior treatment for pancreatic cancer
  2. 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.
  3. Prior biliary bypass surgery
  4. 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
  5. Subjects without baseline tumor imaging
  6. Stenosis or occlusion in intended artery for treatment that precludes IA therapy as determined by CT or MRI
  7. Tortuosity preventing the delivery of the guide sheath and or RenovoCath™ catheter to intended site as determined by CT or MRI
  8. Inability to exclude major side branches in the area of the intended RenovoCath™ occlusion as determined by CT or MRI
  9. 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
  10. Subjects with known HIV or active viral hepatitis
  11. 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
  12. Signs or symptoms of infection within 2 weeks prior to the first study treatment
  13. Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible
  14. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
  15. 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
  16. Subjects with uncontrolled seizures
  17. 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
  18. Life-threatening visceral disease or other severe concurrent disease
  19. 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
  20. Women who are breastfeeding
  21. 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
  22. Subjects concurrently receiving any other investigational agents within 2 weeks prior to the first study treatment
  23. Any psychiatric illness or social situations that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257033


Contacts
Contact: Carole McEvoy 6502844433 caroleann@renovorx.com
Contact: Charles Li 6502844433 Charles@renovorx.com

Locations
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Katherine Schleich         
Principal Investigator: Allen Cohn, MD         
Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC Recruiting
Englewood, Colorado, United States, 80113
Contact: Joanne Hindle         
Principal Investigator: David Trevarthen, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: Alexander Kim, MD    202-444-1321      
Principal Investigator: Alexander Kim, MD         
United States, Florida
21st Century Oncology Recruiting
Fort Myers, Florida, United States, 33907
Contact: Rachel Piacente    239-430-3263    rachel.piacente@21co.com   
Principal Investigator: Mark Bloomston, MD         
Miami Cancer Institute Recruiting
Miami, Florida, United States, 33167
Contact: Ripal Gandhi         
Principal Investigator: Ripal Gandhi, MD         
Principal Investigator: Anonio Ucar, MD         
Sarasota Memorial Health Care System Recruiting
Sarasota, Florida, United States, 34329
Contact: Kenneth Meredith, MD         
Principal Investigator: Kenneth Meredith, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Sharon Jerdonek    504-842-3929    Sharon.jerdonek@ochsner.org   
Principal Investigator: Juan Gimenez, MD         
United States, New York
Montefiore Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Alyssa Asaro    718-920-5636    aasaro@montefiore.org   
Principal Investigator: Peter Muscarella, II, MD         
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kaitlyn Walker    252-744-0456    walkerkai16@ecu.edu   
Principal Investigator: Emmanuel Zervos, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Cancer Institute Clinical Trial Information    503-494-1080      
Principal Investigator: Charles Lopez, MD, PhD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Wendy Lane-Scott    412-864-7688    lanewg@upmc.edu   
Principal Investigator: Amer Zureikat, MD         
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact: Gina Norris    864-241-6251    gnorris@ghs.org   
Principal Investigator: Ki Chung, MD         
Sponsors and Collaborators
RenovoRx
Investigators
Study Chair: Michael J Pishvaian Georgetown University

Responsible Party: RenovoRx
ClinicalTrials.gov Identifier: NCT03257033     History of Changes
Other Study ID Numbers: RR3 [CP-03-001]
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs