PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
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 epirubicin hydrochloride vs PXG and docetaxel.
- Evaluate the activity and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I (PEXG): 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.
- Arm II (PGDX): 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.
Patients may then undergo surgery if the tumor becomes resectable.
Inclusion 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
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 during therapy; every 3 months thereafter
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:
CDR0000642240
NCT ID:
NCT00966706
Start Date:
June 2005
Completion Date:
October 2009
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
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