Status:
COMPLETED
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Duct Cell Adenocarcinoma of the Pancreas
Stage III Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 hyd...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01893294
Start Date
April 1 2013
End Date
October 30 2015
Last Update
March 22 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905