RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2018-03-12

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03257033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 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 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 detail regarding eligibility for subjects who have had biliary stents recently placed is 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	1. Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on their first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies to the first gemcitabine and nab-paclitaxel dose and 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. As determined by the Sponsor: 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

Inclusion Criteria

Exclusion Criteria

1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 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
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 detail regarding eligibility for subjects who have had biliary stents recently placed is 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

1. Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on their first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies to the first gemcitabine and nab-paclitaxel dose and 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. As determined by the Sponsor:
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

Contacts and Locations

Study Contact

Nicki Keller

CONTACT

616-516-1162

tigerpac-clinical@renovorx.com

Leesa Gentry

CONTACT

lgentry@renovorx.com

Principal Investigator

Michael J Pishvaian

STUDY_CHAIR

Johns Hopkins Kimmel Cancer Center

Study Locations (Sites)

VA Loma Linda Healthcare System

Loma Linda, California, 92357

United States

Sutter Cancer Center Sacramento

Sacramento, California, 95816

United States

Rocky Mountain Cancer Centers

Denver, Colorado, 80218

United States

Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC

Englewood, Colorado, 80113

United States

Georgetown University

Washington, District of Columbia, 20057

United States

21st Century Oncology

Fort Myers, Florida, 33907

United States

Miami Cancer Center

Miami, Florida, 33167

United States

Sarasota Memorial Health Care System

Sarasota, Florida, 34329

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

ASCLEPES Research Centers

Weeki Wachee, Florida, 34607

United States

Piedmont-Columbus Regional - John B. Amos Cancer Center

Columbus, Georgia, 31904

United States

University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

United States

LSU Health Shreveport

Shreveport, Louisiana, 71103

United States

Medstar Franklin Square

Baltimore, Maryland, 21237

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766

United States

MD Anderson Cancer Center at Cooper Hospital

Camden, New Jersey, 08103

United States

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, 07960

United States

Albany Stratton VA Medical Center

Albany, New York, 12208

United States

Montefiore Hospital

Bronx, New York, 10461

United States

Columbia University Medical Center

New York, New York, 10032

United States

Levine Cancer Institute - Atrium Health

Charlotte, North Carolina, 28204

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Oklahoma University - Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

United States

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, 29425

United States

Prisma Health (formerly Greenville Health System)

Greenville, South Carolina, 29605

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

VA Puget Sound Health Care System

Seattle, Washington, 98108

United States

West Virginia University Medicine

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: RenovoRx

Michael J Pishvaian, STUDY_CHAIR, Johns Hopkins Kimmel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-12

Study Completion Date2026-09

Study Record Updates

Study Start Date2018-03-12

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced Pancreatic Cancer