Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Conditions
Duct Cell Adenocarcinoma of the Pancreas - Stage III Pancreatic Cancer - Stage IV Pancreatic Cancer
Conditions: official terms
Adenocarcinoma - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gemcitabine hydrochloride Type: Drug
Name: fluorouracil Type: Drug
Name: radiation therapy Type: Radiation
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.)
Location
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Clinical Trials Referral Office - 855-776-0015
Start Date
April 2013
Sponsors
Mayo Clinic
Source
Mayo Clinic
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page