Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer

NCT01893294 | Completed Phase 1 DMC

• 3 other identifiers: MC1241NCI-2013-00798P30CA015083
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0

  Within 72 hours of EUS

• Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0

  4 weeks after completing standard systemic chemotherapy

Study Arms (1)

Treatment (gemcitabine hydrochloride)

EXPERIMENTAL

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; Drug: fluorouracil; Radiation: radiation therapy; Other: laboratory biomarker analysis

Interventions

gemcitabine hydrochloride DRUG

Given IT

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (gemcitabine hydrochloride)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (gemcitabine hydrochloride)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (gemcitabine hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (gemcitabine hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Fluorouracil; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones; Therapeutics; Physical Phenomena

Study Officials

• Michael Levy

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2013
• Primary Completion: October 30, 2015
• Study Completion: October 30, 2015
• Last Updated: March 22, 2017

Record last verified: 2015-10

Locations

US (1)