NCT01167738

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	1250 mg/mq days 1-28 every 4 weeks
DRUG	cisplatin	30 mg/mq on days 1 and 15 every 4 weeks
DRUG	epirubicin	30 mg/mq on days 1 and 15 every 4 weeks
DRUG	gemcitabine	800 mg/mq on days 1 and 15 every 4 weeks
DRUG	metformin	2 g days 1-28 every 4 weeks

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2010-07-22
• Last updated: 2015-04-24

Locations

1 site across 1 country: Italy