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Pancreatic CancerPhase 3NCT00075452

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 38 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma. 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?
gemcitabine hydrochloride and oxaliplatin
How many people
Not given
Where
38 sitesFrance
Study dates
Nov 2003to not given
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma
  • Locally advanced or metastatic disease
  • Unresectable disease
  • Measurable disease
  • At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
  • No adenocarcinoma of the bile ducts or ampulla of Vater
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 5 times normal

Renal

  • Creatinine less than 1.5 times normal
  • No uncontrolled or persistent hypercalcemia

Cardiovascular

  • No serious cardiac failure

Pulmonary

  • No serious respiratory failure

Other

  • Pain must be stabilized or controlled before initiation of study treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other untreatable malignant tumor
  • No serious psychological, familial, social, or geographical condition that would preclude study participation
  • No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • Centre Paul Papin

    Angers, 49036

  • C.H.G. Beauvais

    Beauvais, 60021

  • Hopital Saint Andre

    Bordeaux, 33075

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • CMC Bligny

    Briis-sous-Forges, 91640

  • Hopital Louis Pasteur

    Chartres, 28018

  • Chu-Hopital Gabriel Montpied

    Clermont-Ferrand, F-63000

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Louis Mourier

    Colombes, F-92701

  • Hopital Drevon

    Dijon, 21000

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Hopital Saint - Louis

    La Rochelle, 17000

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Jean Bernard

    Le Mans, 72000

  • C. H. Du Mans

    Le Mans, 72037

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Clinique Saint Jean

    Lyon, 69008

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Intercommunal Hospital

    Montfermeil, 93370

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital de la Croix St. Simon

    Paris, 75020

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Tenon

    Paris, 75970

  • Maison Medicale Marzet

    Pau, 64000

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Clinique Ste - Marie

    Pontoise, 95300

  • Polyclinique De Courlancy

    Reims, F-51100

  • C. H. De Saumur

    Saumur, 49403

  • C.H. Senlis

    Senlis, 60309

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

  • Compare the time of response in patients treated with these regimens.
  • Compare the clinical benefit of and tolerance to these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

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

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Keywords
adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III 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.

What is being measured

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

  1. Overall survival

Secondary outcomes (4)

  1. Time to response

  2. Clinical benefit

  3. Quality of life

  4. Progression-free survival

Timeline

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

  1. First posted12 Jan 2004 (estimated)
  2. Study startNov 2003

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075452
Sponsor's protocol ID
CDR0000346480
Other IDs
FRE-GERCOR-GEM-GEMOX/D00-3, EU-20324
Status last verified
May 2007
First submitted
9 Jan 2004
Last updated
24 Jul 2008
Results posted
No

Publications

  • Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.

    PubMed 17235048

  • Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andre T, Zaniboni A, Ducreux M, Aitini E, Taieb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. doi: 10.1200/JCO.2005.06.023.

    PubMed 15908661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 38 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: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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?

Results are not available in the source record.

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. 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 NCT00075452, which also lists 2 linked publications.

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 24 Jul 2008.

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