Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer
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.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-12
- Completion
- 2015-04
Outcome
Outcome not reported
Stopped: “concern of detrimental effect”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2 g | — |
| Background | Capecitabine | Small molecule | 1250 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 30 mg/m2 | — |
| Background | Epirubicin | Small molecule | 30 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 800 mg/m2 | — |