solid advanced tumors
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically or cytologically proven advanced solid malignancy in patients for whom no better treatment than SU11248 and ifosfamide is available. - Measurable (according to RECIST criteria) or evaluable disease. - At least 4 weeks since any prior anti-tumor therapy and resolution of all toxicities induced by this prior anti-tumor treatment to CTC grade = 18 years. - WHO performance of 0-1 and a predicted life expectancy of at least 3 months. - Adequate organ function defined as follows: serum bilirubin = 60 ml/min and 2 functioning kidneys ANC >= 1.5 x 109/L platelets >= 100 x 109/L hemoglobin >= 6.0 mmol/L - Systolic blood pressure lower than 150 mmHg and diastolic blood pressure lower than 90 mmHg (treatment with 2 antihypertensive drugs is allowed)
Exclusion criteria
Exclusion criteria: - severe/unstable angina or symptomatic congestive heart failure within 12 months prior to inclusion - myocardial infarction, or cerebrovascular accident within 12 months prior to inclusion - atrial fibrillation of any grade or ongoing cardiac dysrhythmias >= grade 2 - known human immunodeficiency virus (HIV) positivity - use of prohibited co-medication as mentioned in paragraph 5.4 - pregnancy and / or breast feeding; for all women of child-bearing potential a negative pregnancy test will be required as well as the willingness to use adequate contraception during the study until 4 weeks after stopping treatment. - signs or symptoms of CNS metastases (radiological assessment of potential CNS metastases is not required). - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. - other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of sunitinib when given in combination with standard doses of ifosfamide. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the impact of sunitinib on ifosfamide pharmacokinetics and vice versa. To evaluate the impact of this combination on surrogate markers including VEGF and soluble VEGF-R plasma levels and the number of circulating endothelial cells (CECs) To record any disease response | — |
Countries
Netherlands
Outcome results
None listed