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Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide (PAL-ANGI2)
The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.
Details
| Lead sponsor | Centre Oscar Lambret |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2011-07-13 |
| Completion | 2013-04 |
Conditions
- Cancer
Interventions
- Paclitaxel dose escalation
- Paclitaxel
- Cyclophosphamide
- Blood collection
Primary outcomes
- Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide — 28 days = cycle 1
A DLT is defined below: Hematological toxicity: * Polynuclear neutrophils \< 500/mm3 for more than 7 days * Febrile neutropenia (Polynuclear neutrophils \< 1 000/mm3 and fever \> or = 38.5°C) or documented infection * Thrombopenia (Platelets \< 25 000/mm3) * Impossibility to administer D8 or D15 due to hematological criteria Non-hematological toxicity: Any grade 3 or 4 toxicity related to study treatment, with the exception of fatigue and alopecia
Countries
France