Pancreatic Cancer
Conditions
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
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, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.
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 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.
Interventions
DRUGcapecitabine
Given systemically
DRUGcisplatin
Given systemically
DRUGdocetaxel
Given systemically
DRUGepirubicin hydrochloride
Given systemically
DRUGgemcitabine hydrochloride
Given systemically
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival at 6-months | every 2 months during therapy; every 3 months thereafter | CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | monthly | — |
| Response rate | every 2 months during therapy; every 3 months thereafter | CT scan |
| Toxicity | every 2 weeks during therapy | outpatient visit |
Countries
Italy
Outcome results
None listed