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

This study is currently recruiting participants.
Verified July 2010 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01167738
First received: July 21, 2010
Last updated: November 4, 2012
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: capecitabine
Drug: cisplatin
Drug: epirubicin
Drug: gemcitabine
Drug: metformin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
    CT scan


Secondary Outcome Measures:
  • Overall survival [ Time Frame: every 14 days during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    outpatient visit, phone interview

  • Response rate [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
    CT scan

  • Toxicity [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    outpatient visit, laboratory findings


Estimated Enrollment: 82
Study Start Date: July 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167738

Locations
Italy
Istituto Scientifico H. San Raffaele Recruiting
Milan, Italy, 20132
Contact: Contact Person, MD     +39-02-2643-7626     reni.michele@hsr.it    
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01167738     History of Changes
Other Study ID Numbers: CDR0000681691, PACT-17, 2010-020979-23
Study First Received: July 21, 2010
Last Updated: November 4, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by 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
Capecitabine
Cisplatin
Epirubicin
Metformin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Hypoglycemic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013