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Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

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ClinicalTrials.gov Identifier: NCT00777504
Recruitment Status : Unknown
Verified September 2011 by Radboud University.
Recruitment status was:  Recruiting
First Posted : October 22, 2008
Last Update Posted : September 16, 2011
Sponsor:
Information provided by (Responsible Party):
Radboud University

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Gastrointestinal Stromal Tumor Drug: usage oral angiogenesis inhibitor Drug: stop oral angiogenesis inhibitor Phase 4

Detailed 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Study Start Date : October 2008
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: usage oral angiogenesis inhibitor
see under 'study arms'
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.
 Drug: stop oral angiogenesis inhibitor
see under 'study arms'


Outcome Measures
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Primary Outcome Measures :
  1. Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Effect on Quality of life as record by questionaires [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777504


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

Locations
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Netherlands
University Medical Center Nijmegen st Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GH
Principal Investigator: C.M.L van Herpen, Md, Phd         
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
More Information
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00777504    
Other Study ID Numbers: UMCNONCO200801
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: September 16, 2011
Last Verified: September 2011
Keywords provided by Radboud University:
angiogenesis
inhibitor
duration of therapy
GIST
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Gastrointestinal Stromal Tumors
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
 Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents