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Trial record 1 of 1 for:    NCT03257033
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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 : Unknown
Verified February 2022 by RenovoRx.
Recruitment status was:  Recruiting
First Posted : August 22, 2017
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
RenovoRx

Study Description
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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 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 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

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Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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 or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent.
  2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team
  3. ECOG performance status 0-1
  4. Age ≥ 18 years

  5. Adequate laboratory values prior to starting the first dose of nab-paclitaxel and gemcitabine:

    1. Absolute neutrophil count ≥ 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. AST and 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 placed or planned to be placed within 6 weeks of Cycle 1 Day 1, total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range
    7. PT and PTT must be ≤ 1.5 X upper normal limit of institution's normal range
    8. INR ≤ 1.5
  6. Life expectancy > 12 weeks
  7. Negative pregnancy test for women of childbearing potential (either serum or urine) within 1 day prior to administration of the first dose of chemotherapy. Women of childbearing potential should only 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

Exclusion Criteria:

  1. Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies in that the first gemcitabine and nab-paclitaxel dose must be within 6 weeks of confirmed diagnosis.
  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. To be determined by the sponsor and not by the site:

    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, which includes the following:

    1. Stenosis or occlusion in 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 3mm in proximity of at least one side of the tumor
    4. Superior mesenteric vein occlusion or stenosis that cannot be resolved with medication or intervention prior to randomization, if the superior mesenteric artery is the only viable treatment artery Note: Arterial Anatomy will be reviewed by the core imaging lab, 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 7cm must be assessed on a case-by-case basis with the Central Radiation Reviewer prior to excluding patient from trial.
  7. Subjects with known HIV or active viral hepatitis
  8. 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
  9. Signs or symptoms of infection within 2 weeks prior to the first study treatment
  10. Received oral or IV antibiotics for an infection within 2 weeks prior to the first 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, 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 NYHA Class III or IV congestive heart failure within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction, congestive heart failure, coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction to ensure EF is not ≤ 40% (based upon MRI, ECHO, or Nuclear Scan), within last 3 months prior to the first study treatment
  15. Other severe concurrent disease, or comorbidities which make it difficult to participate in this study.

  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 first study treatment
  20. Any social situations or psychiatric illness that would limit compliance with study requirements
  21. Subjects unable or unwilling to have standard catherization procedure
Contacts and Locations
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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
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Contact: Carter Hultman 6502844433 chultman@renovorx.com
Contact: Nicole G Lama 6502844433 nlama@renovorx.com

Locations
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Sponsors and Collaborators
RenovoRx
Investigators
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Study Chair: Michael J Pishvaian Johns Hopkins Kimmel Cancer Center
More Information
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Responsible Party: RenovoRx
ClinicalTrials.gov Identifier: NCT03257033    
Other Study ID Numbers: RR3 [CP-03-001]
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
 Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites