A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
A Randomized Phase II Study of Chemotherapy ± Metformin in 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival at 6 months
Outcome Description:
CT scan
Outcome Time Frame:
every 2 months
Safety Issue:
No
Principal Investigator
Michele Reni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Scientifico H. San Raffaele
Authority:
Italy: Ministry of Health
Study ID:
CDR0000681691
NCT ID:
NCT01167738
Start Date:
July 2010
Completion Date:
January 2014
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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