Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

Renal Cell Carcinoma Clinical Trial

Official title: Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy

Clinical Trial Description

Until now, in trials it is common to stop therapy when progressive disease occurs; RECIST criteria are used, in which progressive disease is defined as >20% increase of the sum of the longest diameter of the lesions, or occurence of new lesions. However, angiogenesis inhibitors have a rather cytostatic than cytotoxic effect compared to chemotherapeutics, as a result of which less frequently reduction of tumor volume is being seen.

Often in the centre of the lesion necrosis is shown. Sometimes accompanied with edema; so even tumor volume increase can be the result without real progression being the case. Recently, in our clinic, we found a number of patients, treated with oral angiogenesis inhibitors, a remarkable quickening of progressive disease and complaints after stopping this treatment. Reintroduction of the same or another type of angiogenesis inhibitor subsequently lead to a new stabilization. The causality of this phenomenon is unknown. Perhaps that the inhibitory effect of the angiogenesis is not fully exhausted at the moment that progressive disease on CT is observed. An alternative explanation is contra reaction of longterm angiogenetic inhibition through upregulation of proangiogenic factors with subsequent vascular expansion and edema. This study means to gain more insight information about the optimal treatment policy when progressive disease is found in patients treated with oral angiogenesis inhibitors. Because of the increase of patients that is being treated with these products, both in trials as in daily clinical practice, this is important to investigate. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Renal Cell Carcinoma

• NCT number: NCT00777504
• Study type: Interventional
• Source: Radboud University
• Contact: C.M.L. van Herpen, Md, Phd
• Phone: 31 24 3610353
• Email: c.vanherpen@onco.umcn.nl
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2008
• Completion date: April 2012