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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-16996O |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past PR or CR.
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy.
PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rubitecan | Drug |
DISEASE CHARACTERISTICS:
Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen
Minimum of 1 target lesion that can be accurately measured in at least 1 dimension
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Fumoleau, MD, PhD | Centre Georges Francois Leclerc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | B-1000 | Belgium | |||
| Centre Jean Perrin |
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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 |
|---|---|
| C079905 | rubitecan |
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| Clermont-Ferrand |
| 63011 |
| France |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | Dijon | 21079 | France |
| CHU de la Timone | Marseille | 13385 | France |
| CRLCC Nantes - Atlantique | Nantes-Saint Herblain | 44805 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Rabin Medical Center - Beilinson Campus | Petah Tikva | 49100 | Israel |
| Azienda Ospedaliera di Padova | Padova (Padua) | 35128 | Italy |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Ospedale San Giovanni | Bellinzona | 6500 | Switzerland |
| Clinique De Genolier | Genolier | Ch-1272 | Switzerland |
| Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| 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 |