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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 and over Other UMCNONCO200801 NCT00777504

Trial Description

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

Further Study Information

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 tumorvolume 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 causuality of this phenomenom 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 contrareaction 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.

Eligibility Criteria

Inclusion Criteria:

• metastastic or advanced solid cancer that is treated with an oral angiogenesis inhibitor, with clinical indication to stop this therapy based on progressive disease as defined by the RECIST criteria on the CT scan. It needs a minimum of 1 previous evaluation of stable disease and the patient must have been treated with angiogenesis inhibitors for at least 12 weeks.

• age ≥18 years

• given informed consent

Exclusion Criteria:

• pregnant or lactating

• metastatic sites solely in bone or liver

• contra-indication for CT or Avastinscan (claustrofobia, severe renal function disorder, allergy for contrastfluids, allergy for Avastin)

• insufficient condition to continue treatment with angiogenesis inhibitors.

• contra-indication for dynamic contrast MRI (deteriorated renal functions with clearance <60ml/min, metal in body, claustrofobia, pacemaker, defibrilator)

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitair Medisch Centrum St. Radboud - Nijmegen

C.M.L. van Herpen, MD, Phd

Principal Investigator

C.M.L. van Herpen, Md, Phd		Ph: 31 24 3610353
		Email: c.vanherpen@onco.umcn.nl

Netherlands
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		C.M.L van Herpen, Md, Phd	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00777504
Information obtained from ClinicalTrials.gov on October 22, 2008