Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer (PACT-7)

January 12, 2012 updated by: Michele Reni, IRCCS San Raffaele

Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether gemcitabine hydrochloride is more effective when given alone or together with combination chemotherapy and radiation therapy in treating patients with pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying gemcitabine hydrochloride to see how well it works when given alone or together with combination chemotherapy and radiation therapy in treating patients with stage IB, stage II, or stage III pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Assess the 1-year progression-free survival of patients with stage IB, II, or III adenocarcinoma of the pancreas treated with adjuvant therapy comprising gemcitabine with vs without cisplatin, epirubicin hydrochloride, and fluorouracil followed by chemoradiotherapy with fluorouracil or capecitabine. (Phase II)
  • Compare the 2-year overall survival of patients treated with these regimens. (Phase III)

Secondary

  • Assess the feasibility and toxicity of these regimens in these patients.
  • Assess the impact of these regimens on the quality of life of these patients.
  • Assess the pattern of relapse in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and radical surgery. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-4 weeks after the completion of chemotherapy, patients in both arms undergo radiotherapy 5 days a week for 6 weeks. Patients also receive concurrent fluorouracil IV continuously or oral capecitabine during radiotherapy.

After completion of study treatment, patients are followed up every 3 months.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2
  • Phase 3

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
        • Istituto Scientifico H. San Raffaele

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 confirmed adenocarcinoma of the pancreas

    • Stage IB-III disease
  • Has undergone surgery with radical intent (R0 or R1) within the past 2 months

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100% (90-100% for patients 71-75 years of age)
  • WBC ≥ 3,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2 mg/dL
  • SGOT and SGPT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
  • No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
  • 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 gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • Gemzar
Experimental: Arm II
Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Drug: fluorouracil
Given IV
Other Names:
  • FLuorouracile-TEVA
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • Gemzar
Drug: cisplatin
Given IV
Other Names:
  • Cisplatino-TEVA
Drug: capecitabine
Given orally
Other Names:
  • XELODA
Drug: epirubicin hydrochloride
Given IV
Other Names:
  • Farmarubicina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year progression-free survival (Phase II)
Time Frame: every 3 months during the first 2 years, every 6 months afterwards
every 3 months during the first 2 years, every 6 months afterwards

Secondary Outcome Measures

Outcome Measure
Time Frame
Pattern of relapse
Time Frame: every 3 months during the first 2 years, every 6 months afterwards
every 3 months during the first 2 years, every 6 months afterwards

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2003

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000641309
  • PACT-7 (Other Identifier: IRCCS San Raffaele)

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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