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| ID | Type | Description | Link |
|---|---|---|---|
| GERCOR-D04-1-GEMOX | |||
| EU-20569 | |||
| SANOFI-GERCOR-D04-1-GEMOX |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| oxaliplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefits and tolerability | ||
| Progression-free and overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
Measurable disease (primary tumor or metastasis)
No ampulla of Vater carcinoma or biliary adenocarcinoma
No known brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Louvet, MD, PhD | Hopital Saint Antoine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Duffaut | Avignon | 84902 | France | |||
| C.H.G. Beauvais |
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| Beauvais |
| 60021 |
| France |
| Hopital Drevon | Dijon | 21000 | France |
| Centre Hospitalier de Dreux | Dreux | 28100 | France |
| Centre Hospitalier Departemental | La Roche-sur-Yon | F-85025 | France |
| Hopital Saint - Louis | La Rochelle | 17000 | France |
| Hopital Louis Pasteur - Le Coudray | Le Coudray | 28630 | France |
| Clinique Victor Hugo | Le Mans | F-72000 | France |
| Polyclinique des Quatre Pavillons | Lormont | 33310 | France |
| Clinique Saint Jean | Lyon | 69008 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Tenon | Paris | 75970 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| C.H. Senlis | Senlis | 60309 | France |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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