Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893294
• Other study ID #: MC1241
• Secondary ID: NCI-2013-00798MC
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2013
• Last updated: March 21, 2017
• Start date: April 2013
• Est. completion date: October 30, 2015

Study information

• Verified date: October 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 30, 2015
• Est. primary completion date: October 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

Drug:
• gemcitabine hydrochloride
Given IT
• fluorouracil
Given IV

Radiation:
• radiation therapy
Undergo radiation therapy

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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