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A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02237157
Recruitment Status : Active, not recruiting
First Posted : September 11, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
RenovoRx

Brief Summary:
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine, local delivery Phase 4

Detailed Description:
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas
Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Gemcitabine, Local Delivery
Gemcitabine; 4 cycles, two doses per cycle; dose escalation
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Name: Gemzar




Primary Outcome Measures :
  1. Determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreas [ Time Frame: 1 week post treatment ]

    To establish the Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter.

    One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.



Secondary Outcome Measures :
  1. CA19-9 tumor reduction [ Time Frame: 1 week after treatment ]
    Measurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.



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:

Subjects will be eligible to participate in the study if all of the following criteria are met:

  1. Males and female subjects 18 years of age and older.
  2. Subjects with locally advanced unresectable adenocarcinoma (cytological or histologic proof required) of the pancreas.. Patients with islet cell tumors are not eligible.
  3. No clinical evidence of distant metastases, excluding single liver metastasis and local lymph node involvement. Patients with more than a single liver metastasis and/or other metastases who have already failed systemic chemotherapy and/or are on a break from systemic chemotherapy who are not surgical candidates can also qualify for this study.
  4. Karnofsky Performance Status (KPS) >60.
  5. Adequate renal, and bone marrow function described as:

    1. Leukocytes ≥ 3,000/uL
    2. Absolute neutrophil count ≥ 1,500/uL
    3. Platelets ≥100,000/uL
    4. Serum creatinine ≥2.0 mg/dL. Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.
    5. Hemoglobin ≥8.5 g/dL (may be receiving supportive therapy)
    6. PT/PTT (WNL)
  6. Adequate Hepatic function (endoscopic or percutaneous drainage as needed) described as:

    1. Total bilirubin ≤3 times UNL (less than or equal to 2 mg/dL)
    2. AST (SGOT)/ALT (SGPT) ≤ 5 times ULN or ≤5 times ULN in the setting of liver metastases.
    3. Lipase and Amylase within normal limits.
  7. Capable of understanding the purpose and risks of the study and willing to provide written informed consent and to comply with the procedures

Exclusion Criteria:

Subjects will be excluded from participation in the study if any of the following criteria are met:

  1. Have a known sensitivity to gemcitabine.
  2. Identification of metastatic disease, with the exception of single liver metastases or local lymph node involvement. Patients with more than a single liver metastasis and/or other metastases who have already failed systemic chemotherapy and/or are on a break from systemic chemotherapy who are not surgical candidates can also qualify for this study.
  3. Evidence of coagulopathy.
  4. Inability or unwillingness to comply with study procedures and/or follow-up procedures.
  5. Evidence of infection or other coexisting medical condition, which in the opinion of the investigator would preclude administration of gemcitabine.
  6. Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months.
  7. Female patient who is pregnant, nursing or planning on becoming pregnant.
  8. Current enrollment and participation in another clinical study or prior exposure to an investigational agent within 12 weeks or 5 half-lives (whichever is longer) of anticipated dosing on Day 1 of this study.
  9. Have known brain metastases.
  10. Have had any major surgery within four weeks of enrollment.
  11. Have any clinically detectable ascites.
  12. Have uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  13. Have serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  14. Other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or prostate cancer) not approved by the Medical Monitor (contact MM in event of prior diagnosis with malignancy to discuss enrollment status).
  15. Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.
  16. Have acquired, hereditary or congenital immunodeficiency's including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia or hepatitis.
  17. Have a prior history of a documented hemolytic event.
  18. Is HIV-positive or Hepatitis positive.

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): NCT02237157


Locations
United States, California
El Camino Hospital, Oncology
Mountain View, California, United States, 94040
United States, Florida
Florida Hospital
Tampa, Florida, United States, 33613
Sponsors and Collaborators
RenovoRx
Investigators
Principal Investigator: Jiali Li, MD El Camino Hospital

Responsible Party: RenovoRx
ClinicalTrials.gov Identifier: NCT02237157     History of Changes
Other Study ID Numbers: RR1
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RenovoRx:
pancreatic cancer
unresectable
gemcitabine
device
local delivery
chemoembolization

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