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

April 14, 2021 updated by: RenovoRx

A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital, Oncology
    • Florida
      • Tampa, Florida, United States, 33613
        • Florida Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gemcitabine, Local Delivery (Dose 1)
Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Names:
  • Gemzar
Other: Gemcitabine, Local Delivery (Dose 2)
Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Names:
  • Gemzar
Other: Gemcitabine, Local Delivery (Dose 3)
Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Names:
  • Gemzar
Other: Gemcitabine, Local Delivery (Dose 4)
Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas
Time Frame: 1 week post treatment

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.
1 week post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenovoRx

Investigators

  • Principal Investigator: Jiali Li, MD, El Camino Hospital

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 Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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