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Oxaliplatin Injection |
Eloxatin |
Clinical Trial: Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
This study is currently recruiting patients.
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Purpose
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: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic unresectable pancreatic adenocarcinoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adenocarcinoma of the pancreas stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer | Drug: gemcitabine Drug: oxaliplatin Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Gemcitabine With or Without Oxaliplatin in Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Further Study Details:
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.
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
France
American Hospital of Paris, Neuilly-sur-Seine, F-92202, France; Recruiting
Bertrand Callet, MD 33-1-4641-2525 betrand.callet@ahoaris.org
C. H. De Saumur, Saumur, 49403, France; Recruiting
Michel Maigre 33-2-4153-3030
C. H. Du Mans, Le Mans, 72037, France; Recruiting
Marie-Aude Coulon 33-2-4343-4343
C.H. Senlis, Senlis, 60309, France; Recruiting
Elisabeth Carola, MD 33-3-4421-7000
C.H.G. Beauvais, Beauvais, 60021, France; Recruiting
J.L. Dutel, MD 33-344-112-309 jl.dutel@ch_beauvais.fr
Centre Hospital Universitaire Hop Huriez, Lille, 59037, France; Recruiting
Mohamed Hebbar, MD 33-3-2044-5479 m-hebbar@chru-lille.fr
Centre Hospitalier de Lagny, Lagny Sur Marne, 77405, France; Recruiting
Annie Bellaiche, MD 33-01-6430-7048
Centre Hospitalier Departemental, La Roche-sur-Yon, F-85025, France; Recruiting
Roger Faroux 33-02-5144-6168
Centre Hospitalier Lyon Sud, Pierre-Benite, 69495, France; Recruiting
Gilles Andre Salles, MD, PhD 33-478-861-191 gilles.galles@chu-lyon.fr
Centre Jean Bernard, Le Mans, 72000, France; Recruiting
Gerard Ganem, MD 334-339-1300
Centre Paul Papin, Angers, 49036, France; Recruiting
Guerin 33-2-4135-2700
CHU Ambroise Pare, Boulogne-Billancourt, F-92104, France; Recruiting
Philippe Rougier, MD 33-01-49-095-325 philippe.rougier@apr.ap-hop-paris.fr
CHU Pitie-Salpetriere, Paris, 75651, France; Recruiting
Bernard Brun, MD 33-1-142-178-176
Chu-Hopital Gabriel Montpied, Clermont-Ferrand, F-63000, France; Recruiting
Ointcloux 33-4-7362-5700
Clinique Saint Jean, Lyon, 69008, France; Recruiting
Gerard Gledo, MD 33-4-7878-1010
Clinique Ste - Marie, Pontoise, 95300, France; Recruiting
Marie-Helene Filippi, MD 33-01-3038-5805 mhfilippi@wanovdoo.fr
CMC Bligny, Briis-sous-Forges, 91640, France; Recruiting
Marie-Christine Clavero-Fabri 33-1-6490-7005
Hopital Andre Mignot, Le Chesnay, 78157, France; Recruiting
Jacques Doll 33-01-3963-8901
Hopital Beaujon, Clichy, 92118, France; Recruiting
P. Hammel, MD 33-14-087-5653 pascal.hammel@bju.ap-hop-paris.fr
Hopital Bichat - Claude Bernard, Paris, 75018, France; Recruiting
Thomas Aparicio 33-01-4025-7000 thomas.aparicio@bch.up-hop-paris.fr
Hopital de la Croix Rousse, Lyon, 69317, France; Recruiting
Jean-Louis Gaudin 33-4-7207-1609
Hopital de la Croix St. Simon, Paris, 75020, France; Recruiting
Isabelle Cojean-Zelek 33-1-4464-1600
Hopital Drevon, Dijon, 21000, France; Recruiting
Michel Flesch, MD 33-380-364-822
Hopital Europeen Georges Pompidou, Paris, 75015, France; Recruiting
Bruno Landi, MD 33-1-5609-3555 bruno.landi@hop.egp.ap-hop-paris.fr
Hopital Haut Leveque, Pessac, 33604, France; Recruiting
Jean-Louis Legoux, MD 335-5765-6438 jean-louis.legoux@chu-bordeaux.fr
Hopital Louis Mourier, Colombes, F-92701, France; Recruiting
Jean-Luc Molitor, MD 33-1-47-60-6073
Hopital Louis Pasteur, Chartres, 28018, France; Recruiting
Elizabeth Angellier 33-2-3730-3077
Hopital Notre-Dame de Bon Secours, Metz, 57038, France; Recruiting
Sabine Walter, MD 33-387-553-554 s.walter@chr-metz-thionville.rss.fr
Hopital Robert Boulin, Libourne, 33500, France; Recruiting
Dominique Auby 33-05-5755-3552 dominique.auby@cheibourne.aquisante.fr
Hopital Saint - Louis, La Rochelle, 17000, France; Recruiting
Paitel, MD 33-546-455321 jf.paitel@chlr.rss.fr
Hopital Saint Andre, Bordeaux, 33075, France; Recruiting
Denis Smith 33-5-5679-5679
Hopital Saint Antoine, Paris, 75571, France; Recruiting
Christophe Louvet, MD, PhD 33-1-49-282-343 christophe.louvet@sat.ap-hop-paris.fr
Hopital Saint-Louis, Paris, 75475, France; Recruiting
Christophe Hennequin, PhD 33-1-4249-4949 christophe.hennequin@sls.ap-hop-paris.fr
Hopital Tenon, Paris, 75970, France; Recruiting
Thierry Andre, MD 33-1-6177-0708 thierry.andre@tnn.ap-hop-paris.fr
Institut Gustave Roussy, Villejuif, F-94805, France; Recruiting
Michel Ducreux, MD, PhD 33-1-4211-4308 ducreux@igr.fr
Intercommunal Hospital, Montfermeil, 93370, France; Recruiting
Mostefa Bennamoun, MD 33-1-4850-1808
Maison Medicale Marzet, Pau, 64000, France; Recruiting
Pierre Marti 33-5-5992-7272
Polyclinique De Courlancy, Reims, F-51100, France; Recruiting
Philippe Colin, MD 33-3-2684-0284 colin.courlancy@wanadoo.fr
Study chairs or principal investigators
Christophe Louvet, MD, PhD, Hopital Saint Antoine
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000346480; FRE-GERCOR-GEM-GEMOX/D00-3; EU-20324; NCT00075452
Record last reviewed: December 2003
Last Updated: March 3, 2005
Record first received: January 9, 2004
ClinicalTrials.gov Identifier: NCT00075452
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2003
Last Updated: March 3, 2005
Record first received: January 9, 2004
ClinicalTrials.gov Identifier: NCT00075452
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Eloxatin (Drug Digest)
- Oxaliplatin Injection (Drug Digest)
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