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AzTrials

Extrahepatic Bile Duct CancerPhase 2NCT00010088

Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

A Phase 2 study testing fluorouracil, gemcitabine hydrochloride and leucovorin calcium in people with Extrahepatic Bile Duct Cancer and Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 50 sites in 2 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
fluorouracil, gemcitabine hydrochloride and leucovorin calcium
Type of treatment
Surgery or procedure
How many people
Not given
Where
50 sitesin 2 countries
Study dates
Jan 1999to not given
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

DISEASE CHARACTERISTICS: Histologically confirmed pancreatic or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

France49 sites

  • Clinique De Rochebelle

    Alès, F-30100

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre D'Oncologie Du Pays-Basqu

    Bayonne, F-64100

  • C.H.G. Beauvais

    Beauvais, 60021

  • Institut Bergonie

    Bordeaux, 33076

  • CMC Bligny

    Briis-sous-Forges, 91640

  • Clinique Saint-Jean

    Cagne-sur-Mer, 06800

  • Hopital Fontenoy

    Chartres, 28018

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Drevon

    Dijon, 21000

  • Centre D'Oncologie Dunkerquois

    Dunkirk, 59240

  • Polyclinique De La Foret

    Fontaineblea, 7300

  • CHR de Grenoble - La Tronche

    Grenoble, 38043

  • Centre De Charlebourg

    La Garenne-Colombes, 92250

  • Clinique Du Cap D'OR

    LA Seyne Sur Me, 83500

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Assistance Publique Hopitaux de Marseille Hopitaux Sud

    Marseille, 13274

  • Hopital Notre-Dame de Bon Secours

    Metz, 55038

  • Hopital Clinique Claude Bernard

    Metz, 57070

  • Intercommunal Hospital

    Montfermeil, 93370

  • Centre Hospitalier De Moulins Yzeure

    Moulins, 03006 Cedex

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • CHR Hotel Dieu

    Nantes, 44093

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Laennec

    Paris, 75007

  • Clinique Du Mont Louis

    Paris, 75011

  • Hopital Rothschild

    Paris, 75012

  • Hopital Saint Joseph

    Paris, 75014

  • L'Institut Mutualiste Montsouris Jourdan

    Paris, 75014

  • Hopital Boucicaut

    Paris, 75015

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • Hopital De La Croix

    Paris, Cedex 20

  • Clinique Bizet

    Paris, CEDEX

  • Hopital Haut Leveque

    Pessac, 33604

  • Clinique Ste-Marie

    Pontoise, 95301

  • Hopital Claude Gallien

    Quincy-sous-Sénart, 91480

  • Polyclinique De Courlancy

    Reims, F-51100

  • Oncologie Medicale

    Saint-Jean, 31240

  • Centre du Rouget

    Sarcelles, 95250

  • C.H. Senlis

    Senlis, 60300

  • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

    Toulon, 83056

  • Clinique Pasteur

    Toulouse, 31076

  • Polyclinique Flemming

    Tours, 37000

  • Centre Saint-Yves

    Vannes, 56001

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Luxembourg1 site

  • Hopital de la Ville D'Esch-sur-Alzette

    Esch-sur-Alzette, L-4005

Other trials in Luxembourg

About this study

Official title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

Read the detailed description

OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Keywords
stage II pancreatic cancer, stage III pancreatic cancer, unresectable extrahepatic bile duct cancer, adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Bile Duct Neoplasms, Pancreatic Neoplasms

What participants receive

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

Timeline

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

  1. First posted20 May 2004 (estimated)
  2. Study startJan 1999

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00010088
Sponsor's protocol ID
CDR0000068440
Other IDs
FRE-GERCOR-FOLFUGEM2-D99-3, EU-20024
Status last verified
Apr 2007
First submitted
2 Feb 2001
Last updated
9 Feb 2009
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

  • Andre T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. doi: 10.1016/s0399-8320(04)95042-7.

    PubMed 15646530

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, gemcitabine hydrochloride and leucovorin calcium in people with Extrahepatic Bile Duct Cancer and Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 50 sites in 2 countries.

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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in France, Luxembourg. 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?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00010088, 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 9 Feb 2009.

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