| Added by | llasorsa |
|---|---|
| Last modified by | mollevi |
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial |
| Creator | Pannier et al. |
| Author | Diane Pannier |
| Author | Antoine Adenis |
| Author | Emilie Bogart |
| Author | Eric Dansin |
| Author | Stéphanie Clisant-Delaine |
| Author | Emilie Decoupigny |
| Author | Anne Lesoin |
| Author | Eric Amela |
| Author | Sandrine Ducornet |
| Author | Jean-Pierre Meurant |
| Author | Marie-Cécile Le Deley |
| Author | Nicolas Penel |
| Abstract | BACKGROUND: The primary aim of this trial was to determine the recommended phase II dose (RP2D) of weekly paclitaxel (wP) administered in combination with oral metronomic cyclophosphamide (OMC). METHODS: Patients ??18 years of age with refractory metastatic cancers were eligible if no standard curative measures existed. Paclitaxel was administered IV weekly (D1, D8, D15; D1?=?D28) in combination with a fixed dose of OMC (50 mg twice a day). A 3?+?3 design was used for dose escalation of wP (40 to 75 mg/m2) followed by an expansion cohort at RP2D. Dose-limiting toxicity (DLT) was defined over the first 28-day cycle as grade???3 non-hematological or grade 4 hematological toxicity (NCI-CTCAE v4.0) or any toxicity leading to a dose reduction. RESULTS: In total, 28 pts. (18 in dose-escalation phase and 10 in expansion cohort) were included, and 16/18 pts. enrolled in the dose-escalation phase were evaluable for DLT. DLT occurred in 0/3, 1/6 (neuropathy), 0/3 and 2/4 pts. (hematological toxicity) at doses of 40, 60, 70 and 75 mg/m2 of wP, respectively. The RP2D of wP was 70 mg/m2; 1/10 patients in the expansion phase had a hematological DLT. At RP2D (n?=?14), the maximal grade of drug-related adverse event was Gr1 in three patients, Gr2 in six patients, Gr3 in one patient and Gr4 in one patient (no AE in three patients). At RP2D, a partial response was observed in one patient with lung adenocarcinoma. CONCLUSION: The combination of OMC and wP resulted in an acceptable safety profile, warranting further clinical evaluation. TRIAL REGISTRATION: TRN: NCT01374620 ; date of registration: 16 June 2011. |
| Publication | BMC cancer |
| Volume | 18 |
| Issue | 1 |
| Pages | 775 |
| Date | Jul 31, 2018 |
| Journal Abbr | BMC Cancer |
| Language | eng |
| DOI | 10.1186/s12885-018-4678-x |
| ISSN | 1471-2407 |
| Short Title | Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide |
| Library Catalog | PubMed |
| Extra | PMID: 30064401 PMCID: PMC6069824 |
| Tags | Administration, Metronomic, Administration, Oral, Adolescent, Adult, Aged, Antineoplastic Agents, clinic, Cyclophosphamide, Dose-finding phase 1 trial, Humans, Metronomic cyclophosphamide, Middle Aged, Neoplasms, Paclitaxel, Weekly paclitaxel, Young Adult |
| Date Added | 2019/01/18 - 10:07:26 |
| Date Modified | 2019/05/21 - 13:06:36 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
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