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

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: gemcitabine; Drug: metformin

• Registration Number: NCT01167738
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2014-12
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEXG regimen	capecitabine	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
PEXG regimen + metformin	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
PEXG regimen + metformin	capecitabine	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
PEXG regimen + metformin	cisplatin	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
PEXG regimen + metformin	gemcitabine	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
PEXG regimen + metformin	epirubicin	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
PEXG regimen	cisplatin	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
PEXG regimen	epirubicin	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
PEXG regimen	gemcitabine	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 6 months	every 2 months	CT scan

Secondary Outcome Measures

Name	Time	Method
Overall survival	every 14 days during therapy; every 3 months thereafter	outpatient visit, phone interview
Toxicity	every 2 weeks	outpatient visit, laboratory findings
Response rate	every 2 months	CT scan

Trial Locations

Locations (1)

Istituto Scientifico H. San Raffaele; 🇮🇹 Milan, Italy