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

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Completed
CT.gov ID
NCT00966706
Collaborator
(none)
105
Enrollment
1
Location
2
Arms
52
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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: epirubicin hydrochloride
    Given systemically
    Other Names:
  • FARMARUBICINA

    • Drug: gemcitabine hydrochloride
    Given systemically
    Other Names:
  • GEMZAR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival at 6-months [every 2 months during therapy; every 3 months thereafter]

      CT scan

    Secondary Outcome Measures

    1. Overall survival [monthly]

    2. Response rate [every 2 months during therapy; every 3 months thereafter]

      CT scan

    3. Toxicity [every 2 weeks during therapy]

      outpatient visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Raffaele Scientific Institute Milan Italy 20132

    Sponsors and Collaborators

    • IRCCS San Raffaele

    Investigators

    • Principal Investigator: Michele Reni, MD, Istituto Scientifico H. San Raffaele

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michele Reni, MD, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT00966706
    Other Study ID Numbers:
    • CDR0000642240
    • SRSI-PACT-9
    • 2005-002586-36
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Feb 1, 2012
    Last Verified:
    Aug 1, 2009
    Keywords provided by Michele Reni, MD, IRCCS San Raffaele
    adenocarcinoma of the pancreas
    stage III pancreatic cancer
    stage IV pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine
    Docetaxel
    Capecitabine
    Epirubicin

    Study Results

    No Results Posted as of Feb 1, 2012