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Pancreatic CancerPhase 3NCT00303758

Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

A Phase 3 study testing cisplatin, fluorouracil and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 46 sites in France.

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 fluorouracil, leucovorin, cisplatin, and gemcitabine, 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 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
cisplatin, fluorouracil and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
46 sitesFrance
Study dates
Oct 2005to Mar 2012
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
  • Metastatic disease
  • Unresectable disease
  • Measurable disease, meeting the following criteria:
  • No prior radiotherapy to the only site of measurable disease
  • Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
  • No brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 2 months
  • No contraindication to chemotherapy
  • Creatinine clearance > 60 mL/min
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Alkaline phosphatase < 5 times normal
  • Bilirubin ≤ 3 mg/dL
  • No coronary insufficiency
  • No symptomatic cardiac disease
  • Good hydration possible
  • No Child-Pugh class B or C cirrhosis
  • No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior palliative or adjuvant chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No radiotherapy during or for 4 weeks after study therapy
  • No other concurrent anticancer therapy

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

France46 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier de Blois

    Blois, 41016

  • Centre Hospitalier Universitaire Ambroise Pare - Boulogne

    Boulogne, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • Centre Hospitalier Universitaire d'Amiens

    Caen, 14076

  • Centre Hospitalier de Chalons-en-Champagne

    Châlons-en-Champagne, 51000

  • CHR Clermont Ferrand, Hotel dieu

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Louis Pasteur

    Colmar, 68024

  • Hopital Du Bocage

    Dijon, 21034

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Draguignan

    Draguignan, 83300

  • Centre Hospitalier De Dunkerque - CHD

    Dunkirk, 59240

  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf

    Elbeuf, 76503

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Clinique Pasteur

    Guilherand-Granges, 07500

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Hopital Edouard Herriot

    Lyon, 69437

  • Hopital Saint Joseph

    Marseille, 13008

  • CHU de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Centre Hospitalier de Martigues

    Martigues, 13698

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CHR Hotel Dieu

    Nantes, 44093

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Haut Leveque

    Pessac, 33604

  • Clinique Ste - Marie

    Pontoise, 95301

  • CHU - Robert Debre

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35064

  • Hopital Charles Nicolle

    Rouen, 76031

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

    Saint-Martin-Boulogne, 62280

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321

  • Centre Hospitalier de Semur en Auxois

    Semur-en-Auxois, 21140

  • Centre Hospitalier de Soissons

    Soissons, 02209

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier de Tarbes

    Tarbes, 65013

  • Nouvelle Clinique Generale

    Valence, 26000

Other trials in France

About this study

Official title: Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the percentage of these patients needing second-line therapy.
  • Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

Quality of life is assessed at baseline and then every 2 months.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
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 NCT00303758
Study groupRoleWhat they receive
LV5FU2 simplifié + cisplatine puis gemcitabine si progressionActive comparatorLV5FU2 simplifié + cisplatine puis gemcitabine si progression
Receives: Drug: cisplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium
gemcitabine puis LV5FU2 simplifié + cisplatine si progressionExperimentalgemcitabine puis LV5FU2 simplifié + cisplatine si progression
Receives: Drug: cisplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium

What is being measured

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

  1. Overall survival

    Measured: 2012

Secondary outcomes (5)

  1. Progression-free survival

    Measured: 2012

  2. Toxicity

    Measured: 2012

  3. Quality of life

    Measured: 2012

  4. Percentage of patients needing second-line therapy

    Measured: 2012

  5. Duration of hospitalization

    Measured: 2012

Timeline

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

  1. First posted17 Mar 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2012
  4. Study completionMar 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303758
Sponsor's protocol ID
CDR0000453841
Other IDs
FFCD-0301, EU-20543
Status last verified
Dec 2006
First submitted
15 Mar 2006
Last updated
4 Mar 2014
Results posted
No

Publications

  • Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.

    PubMed 20947887

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, fluorouracil and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 46 sites in France.

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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France. 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 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?

Overall survival (time frame: 2012). 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 NCT00303758, 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 4 Mar 2014.

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