Pancreatic Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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