lung cancer
Conditions
Interventions
The procedure consists of low-dose CT scan, intravenous administration of
[15O]H2O and [11C]docetaxel, PET acquisition for about 70 min and venous blood
sampling during PET scanning. This procedure
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age: 18 years of age or older. - Patients with lung cancer - Patients with a malignant lesion >= 1.5 cm within the chest as measured by Response Evaluation Criteria in Solid Tumors (RECIST). - Life expectancy of at least 12 weeks. - ECOG performance status of 0 - 2. - At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. - Patients must have recovered (CTC 1.5 x 109/L and platelets > 100 x 109/L. - Serum bilirubin 60 ml/min. - Urine dipstick for proteinuria 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate
Exclusion criteria
Exclusion criteria: - Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease). - Patients with squamous lung cancer. - Major surgical procedure, or significant traumatic injury within 28 days prior to administration of bevacizumab (patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study. - Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed). - Serious non-healing wound or ulcer. - Evidence of bleeding diathesis or coagulopathy or history of hemorrhagic disorders. - Presence of a cavitary lesion or evidence of tumour invading or abutting major blood vessels. - Brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression is permitted. - Current or recent (within 10 days prior to administration of bevacizumab) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters. - History of > grade 2 haemoptysis (symptomatic and medical intervention indicated). - Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration. - Nursing mothers.;- Previous treatment with taxanes or bevacizumab. - Concomitant treatment with other anticancer agents or experimental drugs. - Haemoglobin > 6.0 mmol/l. - 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. - Claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in [11C]docetaxel uptake by tumours after admininistration of bevacizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in tumour blood flow after admininistration of bevacizumab. 2. The relation between [11C]docetaxel uptake and blood flow in tumours after administration of bevacizumab. 3. The effect of different time intervals after administration of bevacizumab on [11C]docetaxel uptake and blood flow in tumours. 4. The relation between bevacizumab-induced changes in blood pressure and changes in blood flow as well as changes in [11C]docetaxel uptake in tumours. | — |
Countries
Netherlands
Outcome results
None listed