Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: cisplatin
* Drug: docetaxel
* Drug: epirubicin hydrochloride
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: capecitabine<br>* Given systemically<br>* Other names: XELODA;Drug: cisplatin<br>* Given systemically<br>* Other names: Cisplatino-TEVA;Drug: docetaxel<br>* Given systemically<br>* Other names: TAXOTERE;Drug: gemcitabine hydrochloride<br>* Given systemically<br>* Other names: GEMZAR;|
| Experimental: Arm II<br>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. | Drug: capecitabine<br>* Given systemically<br>* Other names: XELODA;Drug: cisplatin<br>* Given systemically<br>* Other names: Cisplatino-TEVA;Drug: epirubicin hydrochloride<br>* Given systemically<br>* Other names: FARMARUBICINA;Drug: gemcitabine hydrochloride<br>* Given systemically<br>* Other names: GEMZAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6-months | CT scan | every 2 months during therapy; every 3 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | monthly | 
| Response rate | CT scan | every 2 months during therapy; every 3 months thereafter | 
| Toxicity | outpatient visit | every 2 weeks during therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer