Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Primary Purpose
Duct Cell Adenocarcinoma of the Pancreas, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
fluorouracil
radiation therapy
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Duct Cell Adenocarcinoma of the Pancreas
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.)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (gemcitabine hydrochloride)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01893294
First Posted
July 2, 2013
Last Updated
March 21, 2017
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01893294
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
October 30, 2015 (Actual)
Study Completion Date
October 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duct Cell Adenocarcinoma of the Pancreas, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (gemcitabine hydrochloride)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Intervention Description
Given IT
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-fluorouracil, 5-Fluracil, 5-FU
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0
Description
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time Frame
Within 72 hours of EUS
Title
Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0
Description
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time Frame
4 weeks after completing standard systemic chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Levy
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
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