search
Back to results

Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

Primary Purpose

Renal Cell Carcinoma, Gastrointestinal Stromal Tumor

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
usage oral angiogenesis inhibitor
stop oral angiogenesis inhibitor
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring angiogenesis, inhibitor, duration of therapy, GIST

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Medical Center Nijmegen st RadboudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan

Secondary Outcome Measures

Effect on Quality of life as record by questionaires

Full Information

First Posted
October 21, 2008
Last Updated
September 15, 2011
Sponsor
Radboud University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00777504
Brief Title
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Official Title
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Gastrointestinal Stromal Tumor
Keywords
angiogenesis, inhibitor, duration of therapy, GIST

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
usage oral angiogenesis inhibitor
Intervention Description
see under 'study arms'
Intervention Type
Drug
Intervention Name(s)
stop oral angiogenesis inhibitor
Intervention Description
see under 'study arms'
Primary Outcome Measure Information:
Title
Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Effect on Quality of life as record by questionaires
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C.M.L. van Herpen, Md, Phd
Phone
31 24 3610353
Email
c.vanherpen@onco.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.M.L. van Herpen, MD, Phd
Organizational Affiliation
UMCN st Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Nijmegen st Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C.M.L van Herpen, Md, Phd

12. IPD Sharing Statement

Learn more about this trial

Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

We'll reach out to this number within 24 hrs