Phase I dose escalation trial of docetaxel plus curcumin in patients with advanced and metastatic breast cancer
| Autor: | Philippe Chollet, Françoise Gachon, Chantal Barthomeuf, Eloise Planchat, Marie-Ange Mouret-Reynier, Mathilde Bayet-Robert, Marianne Leheurteur, Xavier Durando, Fabrice Kwiatkowski, Catherine Abrial |
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| Rok vydání: | 2010 |
| Předmět: |
Diarrhea
Male Oncology Cancer Research medicine.medical_specialty Curcumin Neutropenia Time Factors Maximum Tolerated Dose medicine.medical_treatment Breast Neoplasms Docetaxel Drug Administration Schedule Breast Neoplasms Male chemistry.chemical_compound Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans In patient Neoplasm Metastasis Aged Aged 80 and over Pharmacology Chemotherapy Dose-Response Relationship Drug business.industry Carcinoma Leukopenia Middle Aged medicine.disease Metastatic breast cancer Clinical trial Treatment Outcome chemistry Tolerability Toxicity Feasibility Studies Molecular Medicine Female Taxoids business Follow-Up Studies medicine.drug |
| Zdroj: | Cancer Biology & Therapy. 9:8-14 |
| ISSN: | 1555-8576 1538-4047 |
| Popis: | Since the improvement of chemotherapy with safe molecules is needed for a better efficacy without supplementary toxicity, we investigated the feasibility and tolerability of the combination of docetaxel and curcumin, a polyphenolic derivative extracted from Curcuma longa root.Fourteen patients were accrued in this open-label phase I trial. At the last dose level of curcumin, three dose-limiting toxicities were observed and two out of three patients at this dose level refused to continue treatment, leading us to define the maximal tolerated dose of curcumin at 8,000 mg/d. Eight patients out of 14 had measurable lesions according to RECIST criteria, with five PR and three SD. Some improvements as biological and clinical responses were observed in most patients.Patients with advanced or metastatic breast cancer were eligible. Docetaxel (100 mg/m(2)) was administered as a 1 h i.v. infusion every 3 w on d 1 for six cycles. Curcumin was orally given from 500 mg/d for seven consecutive d by cycle (from d-4 to d+2) and escalated until a dose-limiting toxicity should occur. The primary endpoint of this study was to determine the maximal tolerated dose of the combination of dose-escalating curcumin and standard dose of docetaxel chemotherapy in advanced and metastatic breast cancer patients. Secondary objectives included toxicity, safety, vascular endothelial growth factor and tumor markers measurements and assessment of objective and clinical responses to the combination therapy.The recommended dose of curcumin is 6,000 mg/d for seven consecutive d every 3 w in combination with a standard dose of docetaxel. From the encouraging efficacy results, a comparative phase II trial of this regimen plus docetaxel versus docetaxel alone is ongoing in advanced and metastatic breast cancer patients. |
| Databáze: | OpenAIRE |
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