Clinical trial · Interventional
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
NCT01893294CI-TRIAL-00026574completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duct Cell Adenocarcinoma of the Pancreas | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gemcitabine hydrochloride)
- description
- 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.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: fluorouracil
- Radiation: radiation therapy
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- 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
- timeFrame
- 4 weeks
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytology proven pancreatic ductal carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0,1 or 2 * Absolute neutrophil count (ANC) \>= 1500 * Platelets (PLT) \>= 100,000 * Hemoglobin (HgB) \> 9.0 g/dL * Total bilirubin \< 2.0 x upper limit of normal (ULN) * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 5 x ULN * Creatinine =\< 1.5 mg/dL * Negative pregnancy test done =\< 14 days prior to registration, for women of childbearing potential only * Provide informed written consent * Imaging, a combination of at least two of the following (computed tomography \[CT\], magnetic resonance imaging \[MRI\], endoscopic ultrasound \[EUS\]) staging the pancreatic mass as "locally advanced" * EUS clinically indicated for staging, and/or celiac neurolysis * Resection declined by surgical staff based on designation of LAPC * Willing to provide blood samples * Willing to receive their standard multimodality therapy at Mayo Clinic, Rochester * Willing to return to Mayo Clinic, Rochester during the observation phase Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Any prior treatment (chemotherapy, radiation) for pancreatic cancer * Other active malignancy =\< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * History of myocardial infarction =\< 168 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Prior pancreatic surgery * Pancreatic tumor histology other than carcinoma (e.g. islet cell, lymphoma, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.