Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
This trial is active, not recruiting.
|Treatments||fluorouracil, gemcitabine hydrochloride, oxaliplatin, radiation therapy|
|Sponsor||Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)|
|Start date||November 2003|
|Trial identifier||NCT00275119, CDR0000454568, EU-20570, GERCOR-D03-1, SANOFI-GERCOR-D03-1|
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Avignon, France||Institut Sainte Catherine||no longer recruiting|
|Bordeaux, France||Clinique Tivoli||no longer recruiting|
|Bordeaux, France||Hopital Saint Andre||no longer recruiting|
|Dijon, France||Hopital Drevon||no longer recruiting|
|Grenoble, France||CHU de Grenoble - Hopital de la Tronche||no longer recruiting|
|La Rochelle, France||Hopital Saint - Louis||no longer recruiting|
|Le Mans, France||Clinique Victor Hugo||no longer recruiting|
|Lyon, France||Clinique Saint Jean||no longer recruiting|
|Marseille, France||Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes||no longer recruiting|
|Paris, France||Hopital Saint Antoine||no longer recruiting|
|Paris, France||Hopital Tenon||no longer recruiting|
Quality of life
Locoregional and metastatic progression-free survival
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Locally advanced, nonresectable disease - Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery - No visceral or peritoneal metastases - No adenocarcinoma of the bile ducts or the ampulla of Vater PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Stable or controlled pain with analgesics - Not pregnant or nursing - Neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine ≤ 1.5 times normal OR < 3 mg/dL - Creatinine clearance ≥ 40 mL/min - Bilirubin ≤ 1.5 times normal - Alkaline phosphatase < 5 times normal - No medical condition that would preclude study treatment - No active infection - Negative pregnancy test - No serious cardiac or respiratory disease - No uncontrolled or persistent hypercalcemia - No pre-existing neuropathy - No biliary or gastro-duodenal obstruction - No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder - No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen) - At least 2 months since prior radiotherapy
|Official title||Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables|
|Description||OBJECTIVES: Primary - Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin. Secondary - Determine the tolerability of this regimen, in both the short- and long-term, in these patients. - Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. - Determine the clinical benefits of this regimen in these patients. - Determine locoregional and metastatic progression-free survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. - Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy. - Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.|
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