Clinical trialPhase 1Completed
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- April 2013
- Expected end
- 30 October 2015
- Enrollment
- 1 participants
- Sites
- 1
- Primary outcomes
- 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
- Sponsor
- Other
- Results posted
- No
- Last update
- 22 March 2017
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Brief summary public domain (ClinicalTrials.gov)
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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.