Clinical trial NCT01893294: Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Official title: Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Duct Cell Adenocarcinoma of the Pancreas
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.)

Primary outcomes:
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:
measure: Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0
timeFrame: Within 72 hours of EUS
measure: Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0
timeFrame: 4 weeks after completing standard systemic chemotherapy
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Levy
role: PRINCIPAL_INVESTIGATOR
References: