Neovastat (AE-941) in refractory renal cell carcinoma patients: report of a phase II trial with two dose levels.

Abstract

BACKGROUND:

renal cell carcinoma (RCC) is a potential target for anti-angiogenic drugs because of its high vascularization. Neovastat (AE-941) is an inhibitor of angiogenesis with a mechanism of action that could prove beneficial in the treatment of RCC. Patients and design A phase II trial was conducted to identify the long-term safety profile of Neovastat in advanced cancer patients and to obtain preliminary information on its efficacy in solid tumors refractory to standard treatments. Neovastat (60 or 240 ml/day) was administered orally (b.i.d.) to 144 patients with solid tumors refractory to standard therapies or for whom no standard treatments were available.

RESULTS:

A survival analysis was conducted on 22 patients with a primary diagnosis of refractory RCC to determine whether the dose of Neovastat had any effect. A significant relationship between dose and survival was observed; the median survival time was significantly longer (16.3 versus 7.1 months; P = 0.01) in patients treated with Neovastat 240 ml/day (n = 14) compared with patients receiving 60 ml/day (n = 8). No dose-limiting toxicity was reported. The most frequent adverse event was taste alteration (13.6%).

CONCLUSIONS:

Neovastat is well tolerated by advanced cancer patients at doses of 60 and 240 ml/day. The higher dose of Neovastat administered in this trial is associated with a survival benefit in RCC, which is not explained by differences in major prognostic factors.

• Authors: G Batist, F Patenaude, P Champagne, D Croteau, C Levinton, C Hariton, B Escudier, E Dupont
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 13 Issue 8 Pg. 1259-63 (Aug 2002) ISSN: 0923-7534 [Print] England
• PMID: 12181250 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Tissue Extracts
• shark cartilage extract

Topics

• Adult
• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Animals
• Carcinoma, Renal Cell (blood supply, drug therapy, pathology)
• Cartilage (chemistry)
• Female
• Humans
• Kidney Neoplasms (blood supply, drug therapy, pathology)
• Male
• Middle Aged
• Sharks
• Survival Rate
• Tissue Extracts (adverse effects, therapeutic use)