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

NCT00075452 | Unknown Phase 3

• 3 other identifiers: CDR0000346480FRE-GERCOR-GEM-GEMOX/D00-3EU-20324
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 38

Brief 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. 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• Time to response

• Clinical benefit

• Quality of life

• Progression-free survival

Interventions

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (38)

Centre Paul Papin

Angers, 49036, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

CMC Bligny

Briis-sous-Forges, 91640, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Chu-Hopital Gabriel Montpied

Clermont-Ferrand, F-63000, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Louis Mourier

Colombes, F-92701, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Hopital Saint - Louis

La Rochelle, 17000, France

Location

Centre Hospitalier de Lagny

Lagny-sur-Marne, 77405, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

C. H. Du Mans

Le Mans, 72037, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital de la Croix St. Simon

Paris, 75020, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Maison Medicale Marzet

Pau, 64000, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Clinique Ste - Marie

Pontoise, 95300, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C. H. De Saumur

Saumur, 49403, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (2)

• 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.

  PMID: 17235048 BACKGROUND

• 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.

  PMID: 15908661 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Christophe Louvet, MD, PhD

  Hopital Saint Antoine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: November 1, 2003
• Last Updated: July 24, 2008

Record last verified: 2007-05

Locations

FR (38)