Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma
Summary
The early relapse of ovarian cancer occurring within 6 months of chemotherapy including platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly of their disease. For relapses occurring between 6 and 12 months, no recommendation occur and few studies are conducted. Therefore it seems interesting to develop a research on intensive chemotherapy using a combination of carboplatin (a drug widely used in most ovarian cancer) with Topotecan , use in a high dose protocol. Topotecan has demonstrated its efficacy in relapse ovarian cancer and its possible use in high doses, a recent study (ITOV01) have demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD set at 9 mg / m² / dx 5 days). This project is a feasibility research of the combination of topotecan and carboplatin in a high dose escalation protocol for early ovarian cancer relapse occurring 6 to 12 months after conventional chemotherapy-based platinum salts.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-03
- Completion
- 2012-03
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Topotecan | Small molecule | 7.5 mg/m2 | — |
| Subject | Topotecan | Small molecule | 8 mg/m2 | — |
| Subject | Topotecan | Small molecule | 8.5 mg/m2 | — |
| Subject | Topotecan | Small molecule | 9 mg/m2 | — |
| Subject | Topotecan | Small molecule | 9.5 mg/m2 | — |
| Subject | Topotecan | Small molecule | 10 mg/m2 | — |