Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer (PACT-9)

January 31, 2012 updated by: Michele Reni, IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • San Raffaele Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: capecitabine
Given systemically
Other Names:
  • XELODA
Drug: cisplatin
Given systemically
Other Names:
  • Cisplatino-TEVA
Drug: docetaxel
Given systemically
Other Names:
  • TAXOTERE
Drug: gemcitabine hydrochloride
Given systemically
Other Names:
  • GEMZAR
Experimental: 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.
Drug: capecitabine
Given systemically
Other Names:
  • XELODA
Drug: cisplatin
Given systemically
Other Names:
  • Cisplatino-TEVA
Drug: gemcitabine hydrochloride
Given systemically
Other Names:
  • GEMZAR
Drug: epirubicin hydrochloride
Given systemically
Other Names:
  • FARMARUBICINA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000642240
  • SRSI-PACT-9 (Other Identifier: IRCCS San Raffaele)
  • 2005-002586-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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