Trials / Completed
CompletedNCT01893294
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gemcitabine hydrochloride | Given IT |
| DRUG | fluorouracil | Given IV |
| RADIATION | radiation therapy | Undergo radiation therapy |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2015-10-30
- Completion
- 2015-10-30
- First posted
- 2013-07-09
- Last updated
- 2017-03-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01893294. Inclusion in this directory is not an endorsement.