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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine, local delivery||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Gemcitabine, Local Delivery
Gemcitabine; 4 cycles, two doses per cycle; dose escalation
Drug: Gemcitabine, local delivery
Intra-arterial targeted drug delivery
Other Name: Gemzar
- 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.
- 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.
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
|United States, California|
|El Camino Hospital, Oncology|
|Mountain View, California, United States, 94040|
|United States, Florida|
|Tampa, Florida, United States, 33613|
|Principal Investigator:||Jiali Li, MD||El Camino Hospital|