Status:
COMPLETED
Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, ei...
Detailed Description
OBJECTIVES: * Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epiru...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00966706
Start Date
June 1 2005
End Date
October 1 2009
Last Update
February 1 2012
Active Locations (1)
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1
San Raffaele Scientific Institute
Milan, Italy, 20132