Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
NCT ID: NCT00010088
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
1999-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
NCT00303758
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
NCT00003029
Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
NCT00275119
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
NCT00003018
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
NCT00024427
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fluorouracil
gemcitabine hydrochloride
leucovorin calcium
conventional surgery
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christophe Louvet, MD, PhD
Role: STUDY_CHAIR
Hopital Saint Antoine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique De Rochebelle
Alès, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre D'Oncologie Du Pays-Basqu
Bayonne, , France
C.H.G. Beauvais
Beauvais, , France
Institut Bergonie
Bordeaux, , France
CMC Bligny
Briis-sous-Forges, , France
Clinique Saint-Jean
Cagne-sur-Mer, , France
Hopital Fontenoy
Chartres, , France
Hopital Beaujon
Clichy, , France
Hopital Drevon
Dijon, , France
Centre D'Oncologie Dunkerquois
Dunkirk, , France
Polyclinique De La Foret
Fontaineblea, , France
CHR de Grenoble - La Tronche
Grenoble, , France
Centre De Charlebourg
La Garenne-Colombes, , France
Clinique Du Cap D'OR
LA Seyne Sur Me, , France
Hopital Andre Mignot
Le Chesnay, , France
Hopital de la Croix Rousse
Lyon, , France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Hopital Clinique Claude Bernard
Metz, , France
Intercommunal Hospital
Montfermeil, , France
Centre Hospitalier De Moulins Yzeure
Moulins, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
CHR Hotel Dieu
Nantes, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Laennec
Paris, , France
Clinique Du Mont Louis
Paris, , France
Hopital Rothschild
Paris, , France
Hopital Saint Joseph
Paris, , France
L'Institut Mutualiste Montsouris Jourdan
Paris, , France
Hopital Boucicaut
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
Hopital De La Croix
Paris, , France
Clinique Bizet
Paris, , France
Hopital Haut Leveque
Pessac, , France
Clinique Ste-Marie
Pontoise, , France
Hopital Claude Gallien
Quincy-sous-Sénart, , France
Polyclinique De Courlancy
Reims, , France
Oncologie Medicale
Saint-Jean, , France
Centre du Rouget
Sarcelles, , France
C.H. Senlis
Senlis, , France
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon, , France
Clinique Pasteur
Toulouse, , France
Polyclinique Flemming
Tours, , France
Centre Saint-Yves
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, , Luxembourg
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FRE-GERCOR-FOLFUGEM2-D99-3
Identifier Type: -
Identifier Source: secondary_id
EU-20024
Identifier Type: -
Identifier Source: secondary_id
CDR0000068440
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.