Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PACT-17  

Official title:

A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01167738
• Other study ID #: CDR0000681691
• Secondary ID: PACT-172010-0209
• Status: Terminated
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: April 23, 2015
• Start date: July 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• capecitabine
1250 mg/mq days 1-28 every 4 weeks
• cisplatin
30 mg/mq on days 1 and 15 every 4 weeks
• epirubicin
30 mg/mq on days 1 and 15 every 4 weeks
• gemcitabine
800 mg/mq on days 1 and 15 every 4 weeks
• metformin
2 g days 1-28 every 4 weeks

Locations

Country	Name	City	State
Italy	Istituto Scientifico H. San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival at 6 months	CT scan	every 2 months	No
Secondary	Overall survival	outpatient visit, phone interview	every 14 days during therapy; every 3 months thereafter	No
Secondary	Response rate	CT scan	every 2 months	No
Secondary	Toxicity	outpatient visit, laboratory findings	every 2 weeks	Yes