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Pancreatic AdenocarcinomaPhase 2SLAPNCT01543412

Second Line Chemotherapy for Advanced Pancreatic Cancer

A Phase 2 study testing FOLFIRI in people with Pancreatic Adenocarcinoma, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 9 sites 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

No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesItaly
Study dates
Jan 2010to Dec 2011
Phase
Phase 2
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

Who may be able to join

  • Signed written informed consent prior to beginning protocol specific procedures
  • Previous chemotherapy with Gemcitabine plus or less Platinoids
  • Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
  • Male or female less than 75 years of age
  • Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced (non-resectable) or metastatic pancreatic cancer
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  • Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
  • ECOG performance status 0 to 1 at study entry
  • Life expectancy: more than 3 months
  • Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
  • Bilirubin level either normal or less than 1.5 x ULN
  • ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
  • Serum creatinine less than 1.5 x ULN
  • Amylase normal or less than 1.5 ULN
  • Effective contraception for both male and female patients if the risk of conception exists
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial

Who cannot join

  • Brain metastases
  • Previous treatment with irinotecan or fluoropyrimidines
  • Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
  • Significant gastrointestinal abnormalities
  • Gilbert's Syndrome
  • Any uncontrolled infections
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  • Known HIV infection
  • Radiotherapy within 4 weeks prior to study entry
  • Any investigational agents 4 weeks prior to entry
  • Known grade 3 or 4 allergic reaction to any of the components of the treatment
  • Known drug abuse or alcohol abuse
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
  • Women who are pregnant or breastfeeding
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
  • Legal incapacity or limited legal capacity

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • Ospedali Riuniti Umberto I - GM Lancisi-G Salesi

    Ancona, Ancona, 60126

  • Ospedali Riuniti, Largo Barozzi, 1

    Bergamo, Bergamo, 24128

  • Fondazione Poliambulanza, Via Bissolati 57

    Brescia, Brescia, 25100

  • Azienda Ospedaliera "Di Liegro"

    Gaeta, Latina, 04024

  • A.O. Carlo Poma - Via Albertoni, 1

    Mantua, Mantova, 46100

  • A.O. Ospedale S.Paolo

    Milan, MI, 20100

  • A.O. S.Salvatore

    Pesaro, PS, 61100

  • Ospedale Morelli

    Sondalo, SO, 23100

  • A.O. Treviglio-Caravaggio, P.le Ospedale n1

    Treviglio, Bergamo, 24047

Other trials in Italy

About this study

Official title: Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study

No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.

Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.

An exploratory study in this setting seem warranted.

Being tested
FOLFIRI
Keywords
FOLFIRI, Metastases, pancreatic adenocarcinoma, locally advanced or metastatic pancreatic adenocarcinoma
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • FOLFIRIDrug

    Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks

Study groups in NCT01543412
Study groupRoleWhat they receive
FOLFIRIExperimentalFolfiri consist of Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1and 2, 5-FU 400 mg/m2 iv bolus on day 1and 2, 5-FU 600 mg/m2 iv by ci for 22 hours on day 1 and 2, repeated every 2 wks The use of antiemetic prophylaxis was decided locally.
Receives: Drug: FOLFIRI

What is being measured

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

  1. Overall Response Rate (RECIST Criteria)

    time from randomization date to date of death from any cause

    Measured: 2 years

Secondary outcomes (3)

  1. Safety and tolerability; Safety (CTC criteria - version 3.0)

    Treatment will consist of 4 combination-chemotherapy cycles and in case of stable or responsive disease, other 4 cycles can be administered at investigator's discretion. Therefore will be administered for up to 6 months Each treatment cycle will consist of 2 weeks, unless the start of the subsequent cycle is delayed, in which case the cycle length will be longer than 4 weeks.

    Measured: 18 months

  2. Overall survival (OS)

    OS is calculated using the Kaplan-Meyer method The principal objective of the trial is to assess the therapeutic activity of FOLFIRI in patients with exocrine pancreas carcinoma.

    The primary activity parameter to be determined is overall response rate.

    Measured: time from first cycle to death

  3. Progression Free Survival

    PFS was calculated using the Kaplan-Meyer method Presence of at least one target lesion measurable by CT scan or MRI in not an irradiated area (and conform with the RECIST criteria)

    Measured: time from first cycle to progression or death

Timeline

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

  1. First posted5 Mar 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2011
  4. Study completionDec 2011

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543412
Sponsor's protocol ID
2008-004637-16
Other IDs
2008
Acronym
SLAP
Status last verified
Feb 2012
First submitted
7 Sep 2010
Last updated
5 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • Zaniboni A, Aitini E, Barni S, Ferrari D, Cascinu S, Catalano V, Valmadre G, Ferrara D, Veltri E, Codignola C, Labianca R. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jun;69(6):1641-5. doi: 10.1007/s00280-012-1875-1. Epub 2012 May 11.

    PubMed 22576338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRI in people with Pancreatic Adenocarcinoma, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 9 sites in Italy.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 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.

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?

Overall Response Rate (RECIST Criteria) (time frame: 2 years). 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 NCT01543412, 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 5 Mar 2012.

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