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

NCT ID: NCT00966706

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

Given systemically

cisplatin

Intervention Type: DRUG

Given systemically

docetaxel

Intervention Type: DRUG

Given systemically

gemcitabine hydrochloride

Intervention Type: DRUG

Given systemically

Arm II

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.

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

Given systemically

cisplatin

Intervention Type: DRUG

Given systemically

epirubicin hydrochloride

Intervention Type: DRUG

Given systemically

gemcitabine hydrochloride

Intervention Type: DRUG

Given systemically

Interventions

capecitabine

Given systemically

Intervention Type: DRUG

cisplatin

Given systemically

Intervention Type: DRUG

docetaxel

Given systemically

Intervention Type: DRUG

epirubicin hydrochloride

Given systemically

Intervention Type: DRUG

gemcitabine hydrochloride

Given systemically

Intervention Type: DRUG

Other Intervention Names

XELODA; Cisplatino-TEVA; TAXOTERE; FARMARUBICINA; GEMZAR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Michele Reni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Reni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico H. San Raffaele

Locations

San Raffaele Scientific Institute

Milan, , Italy

Countries

Italy

Other Identifiers

SRSI-PACT-9

Identifier Type: OTHER

Identifier Source: secondary_id

2005-002586-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000642240

Identifier Type: -

Identifier Source: org_study_id