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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
capecitabine
cisplatin
docetaxel
epirubicin hydrochloride
gemcitabine hydrochloride
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Raffaele Scientific Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival at 6-months
CT scan

Secondary Outcome Measures

Overall survival
Response rate
CT scan
Toxicity
outpatient visit

Full Information

First Posted
August 26, 2009
Last Updated
January 31, 2012
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00966706
Brief Title
Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer
Acronym
PACT-9
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
XELODA
Intervention Description
Given systemically
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Cisplatino-TEVA
Intervention Description
Given systemically
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
TAXOTERE
Intervention Description
Given systemically
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Other Intervention Name(s)
FARMARUBICINA
Intervention Description
Given systemically
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
GEMZAR
Intervention Description
Given systemically
Primary Outcome Measure Information:
Title
Progression-free survival at 6-months
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
monthly
Title
Response rate
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Title
Toxicity
Description
outpatient visit
Time Frame
every 2 weeks during therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
Istituto Scientifico H. San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Scientific Institute
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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