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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-DOCELOX/O-01-1 | |||
| EU-20332 |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| oxaliplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of docetaxel and oxaliplatin | ||
| Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance profile | ||
| Recommended phase III dose | ||
| Efficacy |
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DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer
Measurable or evaluable disease
Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Tournigand | Hopital Saint Antoine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intercommunal Hospital | Montfermeil | 93370 | France | |||
| Hopital Saint Antoine |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Complete pathological response |
| Duration of the objective response |
| Time to progression |
| Paris |
| 75012 |
| France |
| Hopital Tenon | Paris | 75970 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| C.H. Senlis | Senlis | 60309 | France |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |