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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00966706
First received: August 26, 2009
Last updated: January 31, 2012
Last verified: August 2009
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: capecitabine
Drug: cisplatin
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: gemcitabine hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Progression-free survival at 6-months [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan


Secondary Outcome Measures:
  • Overall survival [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan

  • Toxicity [ Time Frame: every 2 weeks during therapy ] [ Designated as safety issue: Yes ]
    outpatient visit


Enrollment: 105
Study Start Date: June 2005
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: XELODA
Drug: cisplatin
Given systemically
Other Name: Cisplatino-TEVA
Drug: docetaxel
Given systemically
Other Name: TAXOTERE
Drug: gemcitabine hydrochloride
Given systemically
Other Name: 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 Name: XELODA
Drug: cisplatin
Given systemically
Other Name: Cisplatino-TEVA
Drug: epirubicin hydrochloride
Given systemically
Other Name: FARMARUBICINA
Drug: gemcitabine hydrochloride
Given systemically
Other Name: GEMZAR

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966706

Locations
Italy
San Raffaele Scientific Institute
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00966706     History of Changes
Other Study ID Numbers: CDR0000642240, SRSI-PACT-9, 2005-002586-36
Study First Received: August 26, 2009
Last Updated: January 31, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Docetaxel
Capecitabine
 Cisplatin
Epirubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013