1. To develop and validate an optimal tracer kinetic model for quantitative analysis of [11C]docetaxel PET studies 2. To study the metabolism of [11C]docetaxel, to compare venous versus arterial sampling and to compare the use of an on-line…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics of [11C]docetaxel
Secondary outcome
1. Comparison venous versus arterial sampling and comparison of an on-line
plasma curve with an IDIF
2. Reproducibility of [11C]docetaxel PET measurements
3. Biodistribution of [11C]docetaxel.
Background summary
Docetaxel is an important cytostatic agent used for the treatment of several
types of cancer such as breast, lung and prostate cancer and is given either as
single agent or in combination therapy. Unfortunately, the response rate of
docetaxel is not 100%. In breast cancer for example, docetaxel usually has a
response rate of about 50%, which results in unnecessary exposure to docetaxel
and a delay of a more effective treatment in these patients. It is suggested
that different pharmacokinetics may be involved according to differences in
response. Ideally, responders should be selected from non-responders before
initiating docetaxel treatment. A PET scan using a tracer dose of
[11C]docetaxel may be useful to predict response of docetaxel therapy in cancer
patients. Furthermore, [11C]docetaxel may be a valuable tool to investigate the
effects of combination therapy (for example with trastuzumab or bevacizumab) on
the uptake of docetaxel in cancer. A feasibility study to image [11C]docetaxel
kinetics in patients with advanced cancer is the first step to evaluate
[11C]docetaxel as tracer for PET imaging.
Study objective
1. To develop and validate an optimal tracer kinetic model for quantitative
analysis of [11C]docetaxel PET studies
2. To study the metabolism of [11C]docetaxel, to compare venous versus
arterial sampling and to compare the use of an on-line measurement plasma curve
with an image derived input function (IDIF)
3. To define test-retest reproducibility of [11C]docetaxel-PET measurements
4. To study the biodistribution of a tracer dose of [11C]docetaxel in patients
with advanced solid tumors.
Objectives can be addressed with a single study in 10 evaluable patients.
Study design
An observational study with invasive measurements.
Study burden and risks
This study with[11C]docetaxel is only justified in population of patients with
advanced solid tumors who are planned to receive chemotherapy. There is only a
little chance for injury. The arterial and venous cannula can cause a hematoma.
During PET-CT scanning a maximum of 250 ml blood will be taken.
A PET-CT is a regular diagnostic imaging technique. The whole body radiation
after intravenous injection of 370 MBq [11C]docetaxel is 2X2 mSv.
In addition a low dose CT scan performed during PET scanning has a
radioactivity dose of 1-3 mSv. The total amount of radiation burden will be
between 6 and 10 mSv during the entire study. To compare, every person living
in the Netherlands receives a the radioactivity dose from the universe and the
environment of 2-2,5 mSv per year.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Patient age of 18-70 years
- Patients with advanced cancer planned to receive chemotherapy
- Life expectancy of at least 12 weeks
- Disease with a malignant lesion of at least 1,5 cm diameter within the chest as measured by Response Evaluation Criteria in Solid Tumors (RECIST)
- Performance status Karnofsky index > 60 %
- Hemoglobin > 6.0 mmol/l
- Written informed consent
Exclusion criteria
- Previous treatment with taxanes
- Claustrophobia
- Pregnant or lactating patients
- Patients having metal implants (e.g. pacemakers)
- Due to the fact that docetaxel is a substrate for P-glycoprotein (P-gp), patients using P-gp drugs like digoxin, cyclosporin, amiodarone, steroids, quinidine, colchicine, etoposide, anti-estrogens will be excluded
- Use of coumarin derivatives or inhibitors of thrombocyte aggregation
- Concurrent treatment with experimental drugs
- Participation in a clinical trial with any investigational drug within 30 days prior to study entry
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17159.029.07 |