Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00777504
First received: October 21, 2008
Last updated: September 15, 2011
Last verified: September 2011

October 21, 2008
September 15, 2011
October 2008
January 2012   (final data collection date for primary outcome measure)
Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Signs of progresive disease on CT-scan, DCE-MRI or Avastinscan [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00777504 on ClinicalTrials.gov Archive Site
Effect on Quality of life as record by questionaires [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Carcinoma
  • Gastrointestinal Stromal Tumor
  • Drug: usage oral angiogenesis inhibitor
    see under 'study arms'
  • Drug: stop oral angiogenesis inhibitor
    see under 'study arms'
  • Active Comparator: A
    When PD is being determined the patient will continue with the oral angiogenesis inhibitors for 2 more weeks. After 2 weeks, an Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI). After evaluating these scans patients in group A now stop the orale angiogenesis inhibitor.
    Intervention: Drug: usage oral angiogenesis inhibitor
  • Active Comparator: B
    When PD is being determined the patient will continue with the oral angiogenesis inhibitors for 2 more weeks. After 2 weeks, an Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI). After evaluating these scans patients in group B continue with angiogenesis inhibitors for 2 more weeks. After these 2 weeks(so 4 weeks after inclusion) another Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI) and a FDG-PET-scan.
    Intervention: Drug: stop oral angiogenesis inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • metastatic 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
  • contraindication for CT or Avastin scan (claustrophobia, severe renal function disorder, allergy for contrast fluids, allergy for Avastin)
  • insufficient condition to continue treatment with angiogenesis inhibitors.
  • contraindication for dynamic contrast MRI (deteriorated renal functions with clearance <60ml/min, metal in body, claustrophobia, pacemaker, defibrillator)
Both
18 Years and older
No
Contact: C.M.L. van Herpen, Md, Phd 31 24 3610353 c.vanherpen@onco.umcn.nl
Netherlands
 
NCT00777504
UMCNONCO200801
Yes
Radboud University
Radboud University
Not Provided
Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
Radboud University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP