Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01893294|
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Duct Cell Adenocarcinoma of the Pancreas Stage III Pancreatic Cancer Stage IV Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: fluorouracil Radiation: radiation therapy Other: laboratory biomarker analysis||Phase 1|
I. To determine the maximum tolerate dose (MTD) of intra-tumoral injection of gemcitabine (gemcitabine hydrochloride) when administered as a one time initial induction therapy in conjunction (=< 33 hours) prior to conventional multimodality treatment for locally advanced pancreatic cancer (LAPC).
I. To evaluate the initial and delayed toxicity associated with this treatment regimen.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine hydrochloride intratumorally (IT) on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil intravenously (IV) on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
After completion of study treatment, patients are followed up for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 30, 2015|
|Actual Study Completion Date :||October 30, 2015|
Experimental: Treatment (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IT on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil IV on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Undergo radiation therapy
Other: laboratory biomarker analysis
- MTD of gemcitabine hydrochloride defined as the dose at which no more than 3 of 6 patients experience grade 3 or greater adverse events, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 4 weeks ]
- Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0 [ Time Frame: Within 72 hours of EUS ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0 [ Time Frame: 4 weeks after completing standard systemic chemotherapy ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
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): NCT01893294
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michael Levy||Mayo Clinic|