2015-03
2016-09
2016-09
20
NCT02237157
RenovoRx
RenovoRx
INTERVENTIONAL
A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer
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.
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.
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 | Results Reporting Dates | Study Record Updates |
---|---|---|
2014-09-08 | 2018-12-06 | 2021-04-14 |
2014-09-10 | 2021-04-14 | 2021-05-07 |
2014-09-11 | 2021-05-07 | 2021-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
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
|
OTHER: Gemcitabine, Local Delivery (Dose 2) Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose | DRUG: Gemcitabine, local delivery
|
OTHER: Gemcitabine, Local Delivery (Dose 3) Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose | DRUG: Gemcitabine, local delivery
|
OTHER: Gemcitabine, Local Delivery (Dose 4) Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose | DRUG: Gemcitabine, local delivery
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas | 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 | Measure Description | Time Frame |
---|---|---|
CA19-9 Tumor Reduction | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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