Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer (PACT-17)
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
capecitabine
cisplatin
epirubicin
gemcitabine
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
- Metastatic (stage IV) disease
- Measurable disease
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- Adequate bone marrow, liver and kidney function
- No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
- No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
- No alcohol abuse
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or metformin
- No other concurrent experimental drugs
Sites / Locations
- Istituto Scientifico H. San Raffaele
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PEXG regimen + metformin
PEXG regimen
Arm Description
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
Outcomes
Primary Outcome Measures
Progression-free survival at 6 months
CT scan
Secondary Outcome Measures
Overall survival
outpatient visit, phone interview
Response rate
CT scan
Toxicity
outpatient visit, laboratory findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01167738
Brief Title
Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer
Acronym
PACT-17
Official Title
A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
concern of detrimental effect
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.
PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.
Detailed Description
OBJECTIVES:
Primary
To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.
Secondary
To assess the overall survival of patients treated with this regimen.
To assess the response rate in patients treated with this regimen.
To assess the duration of response in patients treated with this regimen.
To assess the toxicity in patients treated with this regimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEXG regimen + metformin
Arm Type
Experimental
Arm Description
cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28
Arm Title
PEXG regimen
Arm Type
Active Comparator
Arm Description
cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
XELODA
Intervention Description
1250 mg/mq days 1-28 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
cisplatino TEVA
Intervention Description
30 mg/mq on days 1 and 15 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
epirubicin
Other Intervention Name(s)
farmorubicina
Intervention Description
30 mg/mq on days 1 and 15 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
GEMZAR
Intervention Description
800 mg/mq on days 1 and 15 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
glucophage
Intervention Description
2 g days 1-28 every 4 weeks
Primary Outcome Measure Information:
Title
Progression-free survival at 6 months
Description
CT scan
Time Frame
every 2 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
outpatient visit, phone interview
Time Frame
every 14 days during therapy; every 3 months thereafter
Title
Response rate
Description
CT scan
Time Frame
every 2 months
Title
Toxicity
Description
outpatient visit, laboratory findings
Time Frame
every 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
Metastatic (stage IV) disease
Measurable disease
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
Not pregnant or nursing
Adequate bone marrow, liver and kidney function
No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
No alcohol abuse
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or metformin
No other concurrent experimental drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
Istituto Scientifico H. San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Scientifico H. San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer
We'll reach out to this number within 24 hrs