Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer (PACT-9)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas
- Stage III or IV disease
- Measurable disease
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Adequate bone marrow, liver, and kidney function
- Not pregnant or nursing
- No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin
No multiple severe diseases that can compromise study safety, including any of the following:
- Cardiac failure
- Myocardial infarction within the past 4 months
- Cardiac arrhythmia
- History of psychiatric disabilities
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for pancreatic cancer
- No other concurrent experimental drugs
Sites / Locations
- San Raffaele Scientific Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.