Phase II study of IV vinflunine in patients with chemotherapy naive metastatic malignant melanoma

Olver, I.; Byrne, Michael; Walpole, Euan; Vorobiof, Daniel; Jacobs, C.; Maart, K.; Hewitt, Susan; McAdam, G.; Pouget, Jean-Christophe; Pinel, M. C.

doi:10.1016/j.ejca.2007.05.030

Cited by 12 publications

(4 citation statements)

References 16 publications

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“…Because of its broader spectrum of activity and advantages over other Vinca alkaloids, VFL has been evaluated as monotherapy and as combination chemotherapy in a number of different cancers, including breast cancer, [60][61][62][63][64][65][66] NSCLC, [67][68][69][70][71] small cell lung cancer (SCLC), 72,73 prostate cancer, 74 gastric cancer, 75 malignant pleural mesothelioma [76][77][78] and renal cell carcinoma. 79 The recommended dose for clinical studies is 320 mg/m 2 administered intravenously every 21 days.…”

Section: Clinical Trialsmentioning

confidence: 99%

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

Morel¹,

Talbot²

2010

RRU

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Urothelial carcinoma (UC) accounts for 5% to 10% of malignancies in men in Europe and the United States. For locally advanced or metastatic disease, there are two standard firstline chemotherapy regimens: MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) and gemcitabine/cisplatin. For refractory disease, there is currently no standard treatment. Vinflunine, a second-generation Vinca alkaloid, is the first chemotherapeutic agent to be evaluated in a large UC second-line population. This review discusses the pre-clinical and clinical data published, and compares vinflunine to alternative single agents and combination regimens tested in this setting. Based on the results of the phase II and III clinical trials, there appears to be sufficient evidence to support the use of vinflunine in the second-line setting.

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Section: Clinical Trialsmentioning

confidence: 99%

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

Morel¹,

Talbot²

2010

RRU

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“…Vinflunine disrupts the functions of endothelial cells of already formed vasculature and is anti‐angiogenic (Kruczynski et al ., ). It is presently in phase III clinical trials for treatment of bladder cancer, nonsmall‐cell lung cancer (Jacquesy and Jouannetaud, ) and malignant melanoma (Olver et al ., ). Several techniques had been reported for vinflunine quantification in plasma samples (Zhao et al ., ; Zorza et al ., ).…”

Section: Introductionmentioning

confidence: 97%

A validated LC‐MS/MS method for the determination of vinflunine in plasma and its application to pharmacokinetic studies

Lü

et al. 2011

Biomedical Chromatography

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A rapid, simple and sensitive LC-MS/MS method for the quantification of vinflunine in plasma was developed and validated. The analysis involved a simple liquid-liquid extraction. After making alkaline with NaOH, plasma was extracted with methyl tert-butyl ether and the organic extract was then evaporated and the residue was reconstituted in mobile phase. The reconstituted solution was injected into an HPLC system and was subjected to reverse-phase HPLC on a 5 µm ODS-3 column at a flow-rate of 0.2 mL/min. The mobile phase consisted of ammonium acetate (0.02 mol/L, pH = 3.0) and acetonitrile (20:80). Vinflunine was detected in the single ion monitoring mode using target ions at m/z 817.4/160.1/142.3 for vinflunine and m/z 447.2/128.3/112.1 for gefitinib (internal standard). Standard curves were linear over the concentration range of 5-1000 ng/mL. The mean predicted concentrations of the quality control samples deviated by less than 2% from the corresponding nominal values; the intra-assay and inter-assay precisions of the assay were within 7% relative standard deviation. The extraction recovery of vinflunine was more than 80%. The validated assay was applied to a pharmacokinetic study of vinflunine in plasma following the administration of a single vinflunine injection (2 mg/kg).

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“…There was no evidence from phase II trials that vinflunine had satisfactory activity in the treatment of metastatic malignant melanoma (35), renal cell carcinoma (36), or colorectal cancer (ref. 37; Table 4).…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Vinflunine: A New Microtubule Inhibitor Agent

Bennouna

Delord

Campone

et al. 2008

Clinical Cancer Research

105

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Vinflunine (Javlor) is the first fluorinated microtubule inhibitor belonging to the Vinca alkaloids family.Vinflunine is obtained by semisynthesis using superacidic chemistry to selectively introduce two fluorine atoms at the 20 ¶ position of the catharanthine moiety. This compound has been selected for clinical development on the basis of encouraging preclinical activity that warrants study in patients with a wide spectrum of solid tumors. Clinically significant activity has been seen in phase II studies, mainly in the treatment of transitional cell carcinoma of the urothelial tract, non^small cell lung cancer, and carcinoma of the breast. Vinflunine is currently in phase III trial assessment in patients with (second line) transitional cell carcinoma of the urothelium and firstline advanced breast cancer. The efficacy of vinflunine in patients with advanced non^small cell lung cancer previously treated with a platinum-containing regimen was confirmed by a large phase III trial.

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Phase II study of IV vinflunine in patients with chemotherapy naive metastatic malignant melanoma

Cited by 12 publications

References 16 publications

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

A validated LC‐MS/MS method for the determination of vinflunine in plasma and its application to pharmacokinetic studies

Vinflunine: A New Microtubule Inhibitor Agent

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