- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777504
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GH
- Recruiting
- University Medical Center Nijmegen st Radboud
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
see under 'study arms'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect on Quality of life as record by questionaires
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Kidney Neoplasms
- Neoplasms, Connective Tissue
- Carcinoma, Renal Cell
- Gastrointestinal Stromal Tumors
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Angiogenesis Inhibitors
Other Study ID Numbers
- UMCNONCO200801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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