Gemcitabine Hydrochloride In Treating Patients With Locally Advanced Pancreatic Cancer

Study Overview

Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer

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.

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.

Duct Cell Adenocarcinoma of the Pancreas
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: fluorouracil
RADIATION: radiation therapy
OTHER: laboratory biomarker analysis

MC1241
NCI-2013-00798 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
MC1241 (OTHER Identifier) (OTHER: Mayo Clinic)
P30CA015083 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-07-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-21
First Submitted that Met QC Criteria 2013-07-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-22
First Posted (ACTUAL) 2013-07-09	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (gemcitabine hydrochloride) 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.	DRUG: gemcitabine hydrochloride Given IT DRUG: fluorouracil Given IV RADIATION: radiation therapy Undergo radiation therapy OTHER: laboratory biomarker analysis Correlative studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (gemcitabine hydrochloride)

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.

DRUG: gemcitabine hydrochloride

Given IT

DRUG: fluorouracil

Given IV

RADIATION: radiation therapy

Undergo radiation therapy

OTHER: laboratory biomarker analysis

Correlative studies

Primary Outcome Measures	Measure Description	Time Frame
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		4 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0	The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.	Within 72 hours of EUS
Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0	The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.	4 weeks after completing standard systemic chemotherapy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Michael Levy, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record