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Pancreatic CancerPhase 2/3PACT-7NCT00960284

Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer

A Phase 2/3 study testing capecitabine, cisplatin and epirubicin hydrochloride in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
capecitabine, cisplatin and epirubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteItaly
Study dates
Jun 2003to Jun 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Scientifico H. San Raffaele

    Milan, 20132

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
capecitabine, cisplatin, epirubicin hydrochloride, fluorouracil, gemcitabine hydrochloride
Keywords
stage IB pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00960284
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: gemcitabine hydrochloride
Arm IIExperimentalPatients 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.
Receives: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year progression-free survival (Phase II)

    Measured: every 3 months during the first 2 years, every 6 months afterwards

Secondary outcomes (1)

  1. Pattern of relapse

    Measured: every 3 months during the first 2 years, every 6 months afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2009 (estimated)
  2. Study startJun 2003
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00960284
Sponsor's protocol ID
CDR0000641309
Other IDs
PACT-7
Acronym
PACT-7
Status last verified
Jan 2012
First submitted
14 Aug 2009
Last updated
13 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Reni M, Passoni P, Bonetto E, Balzano G, Panucci MG, Zerbi A, Ronzoni M, Staudacher C, Villa E, Di Carlo V. Final results of a prospective trial of a PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma. Oncology. 2005;68(2-3):239-45. doi: 10.1159/000086780. Epub 2005 Jul 7.

    PubMed 16015040

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing capecitabine, cisplatin and epirubicin hydrochloride in people with Pancreatic Cancer, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression-free survival (Phase II) (time frame: every 3 months during the first 2 years, every 6 months afterwards). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.

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