ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer (PACT-17)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167738
Recruitment Status : Terminated (concern of detrimental effect)
First Posted : July 22, 2010
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: capecitabine Drug: cisplatin Drug: epirubicin Drug: gemcitabine Drug: metformin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
Study Start Date : July 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PEXG regimen + metformin
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
Drug: capecitabine
1250 mg/mq days 1-28 every 4 weeks
Other Name: XELODA
Drug: cisplatin
30 mg/mq on days 1 and 15 every 4 weeks
Other Name: cisplatino TEVA
Drug: epirubicin
30 mg/mq on days 1 and 15 every 4 weeks
Other Name: farmorubicina
Drug: gemcitabine
800 mg/mq on days 1 and 15 every 4 weeks
Other Name: GEMZAR
Drug: metformin
2 g days 1-28 every 4 weeks
Other Name: glucophage
Active Comparator: PEXG regimen
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
Drug: capecitabine
1250 mg/mq days 1-28 every 4 weeks
Other Name: XELODA
Drug: cisplatin
30 mg/mq on days 1 and 15 every 4 weeks
Other Name: cisplatino TEVA
Drug: epirubicin
30 mg/mq on days 1 and 15 every 4 weeks
Other Name: farmorubicina
Drug: gemcitabine
800 mg/mq on days 1 and 15 every 4 weeks
Other Name: GEMZAR



Primary Outcome Measures :
  1. Progression-free survival at 6 months [ Time Frame: every 2 months ]
    CT scan


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: every 14 days during therapy; every 3 months thereafter ]
    outpatient visit, phone interview

  2. Response rate [ Time Frame: every 2 months ]
    CT scan

  3. Toxicity [ Time Frame: every 2 weeks ]
    outpatient visit, laboratory findings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167738


Locations
Italy
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01167738     History of Changes
Other Study ID Numbers: CDR0000681691
PACT-17 ( Other Identifier: IRCCS San Raffaele )
2010-020979-23 ( EudraCT Number )
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Michele Reni, IRCCS San Raffaele:
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Capecitabine
Epirubicin
Metformin
Antineoplastic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors