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| ID | Type | Description | Link |
|---|---|---|---|
| GERCOR-SEGEMOX-S04-1 | |||
| LILLY-GERCOR-SEGEMOX-S04-1 | |||
| SANOFI-GERCOR-SEGEMOX-S04-1 | |||
| EU-20571 |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 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 benefit | ||
| Tolerability | ||
| Progression-free |
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DISEASE CHARACTERISTICS:
Histologically confirmed cancer
Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
Not a candidate for anthracycline or taxane chemotherapy
No brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Gligorov, MD | Hopital Tenon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.G. Beauvais | Beauvais | 60021 | France | |||
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
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| Overall survival |
| Besançon |
| 25030 |
| France |
| Centre Hospitalier Docteur Duchenne | Boulogne-sur-Mer | 62200 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Intercommunal Hospital | Montfermeil | 93370 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Tenon | Paris | 75970 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
| Centre Hospitalier de Saint-Quentin | Saint-Quentin | 02321 | France |
| C.H. Senlis | Senlis | 60309 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer | Toulon | 83056 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| 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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