Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00006117
Last Updated: 2009-10-30
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
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed Description
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OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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gemcitabine hydrochloride
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Adequate cardiac function Pulmonary: Adequate respiratory function Other: Not pregnant or nursing Fertile patients must use effective contraception No sensitive neuropathy No other active malignancy No uncontrolled hypercalcemia No significant medical or psychiatric condition that would preclude study No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroid use except as antiemetic Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Christophe Louvet, MD, PhD
Role: STUDY_CHAIR
Hopital Saint Antoine
Locations
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Institut Jules Bordet
Brussels, , Belgium
Centre Paul Papin
Angers, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Hopital Beaujon
Clichy, , France
Hopital Drevon
Dijon, , France
Clinique Saint Jean
Lyon, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
Polyclinique De Courlancy
Reims, , France
Countries
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References
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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.
Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, Andre T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.
Louvet C, Andre T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8. doi: 10.1200/JCO.2002.20.6.1512.
Other Identifiers
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FRE-GERCOR-GEMOX-D99-2
Identifier Type: -
Identifier Source: secondary_id
EU-20027
Identifier Type: -
Identifier Source: secondary_id
CDR0000068130
Identifier Type: -
Identifier Source: org_study_id