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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 : Recruiting
First Posted : August 22, 2017
Last Update Posted : April 7, 2020
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 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.

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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


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



Information from the National Library of Medicine

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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 (as confirmed by CT or MRI within 30 days of the first on study treatment).
  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. Prior to the initiation of the first on study treatment (Cycle 1/Day 1):

    1. Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range, or
    2. Total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range if biliary stent placed or planned to be placed within 6 weeks of Cycle 1/Day 1
  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. Women of childbearing potential should only use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation.
  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. If all other inclusion/exclusion criteria are met, and with prior written approval from sponsor, an exception may be granted for subjects who have had up to one prior treatment cycle with gemcitabine/nab-paclitaxel as this regimen is standard of care and part of the initial induction treatment on the protocol. 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/nab-paclitaxel dose must be within six weeks of 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 three weeks of the post induction imaging and within 5 weeks of their last induction treatment
  4. Subjects without baseline tumor imaging
  5. Anatomy suitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined by the sponsor, which precludes the following:

    1. Stenosis or occlusion in intended artery for treatment
    2. Tortuosity preventing the delivery of the guide sheath and or RenovoCath® catheter to intended site
    3. Inability to exclude major side branches in the area of the intended RenovoCath® occlusion
    4. No suitable artery with a diameter greater than 3mm in proximity of at least one side of the tumor Note: Suitable anatomy will be reviewed by RenovoRx Imaging Advisor after receipt of initial CT or MRI.
  6. Subjects with known HIV or active viral hepatitis
  7. 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
  8. Signs or symptoms of infection within 2 weeks prior to the first study treatment
  9. Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible.
  10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
  11. 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
  12. Subjects with uncontrolled seizures
  13. 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 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%, within last 3 months prior to the first study treatment.
  14. Life-threatening visceral disease, other severe concurrent disease, or comorbidities which make it difficult to participate in the study
  15. Any of the following procedures prior to initiation of study treatment:

    1. Catheterization, endoscopy, stent or drain placement, within 48 hours, and laparoscopy without surgical intervention can be in less than 48 hours
    2. Minor surgery requiring light sedation, (such as surgical laparoscopy) within 2 weeks
    3. Major surgery within 4 weeks
  16. Women who are breastfeeding
  17. 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 6 months after last study treatment
  18. Subjects receiving any other investigational agents within 2 weeks prior to the first study treatment
  19. Any psychiatric illness or social situations that would limit compliance with study requirements
  20. Subjects unable or unwilling to have standard catheterization procedure.

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: Charles Li 6502844433 charles@renovorx.com
Contact: Nicole G Lama 6502844433 nlama@renovorx.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
RenovoRx
Investigators
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Study Chair: Michael J Pishvaian M.D. Anderson Cancer Center

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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: April 7, 2020
Last Verified: April 2020

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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
Gemcitabine
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