Pancreatic Cancer
Conditions
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer
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.
Interventions
DRUGcapecitabine
1250 mg/mq days 1-28 every 4 weeks
DRUGcisplatin
30 mg/mq on days 1 and 15 every 4 weeks
DRUGepirubicin
30 mg/mq on days 1 and 15 every 4 weeks
DRUGgemcitabine
800 mg/mq on days 1 and 15 every 4 weeks
DRUGmetformin
2 g days 1-28 every 4 weeks
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival at 6 months | every 2 months | CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | every 14 days during therapy; every 3 months thereafter | outpatient visit, phone interview |
| Response rate | every 2 months | CT scan |
| Toxicity | every 2 weeks | outpatient visit, laboratory findings |
Countries
Italy
Outcome results
None listed