A phase I study of the combination of daily oral SU11248 (Sunitinib) with intravenous ifosfamide in patients with advanced solid malignancies.
- Conditions
- solid advanced tumors10027656
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
- 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 <= 1 (if not specified below) except alopecia.
- Age >= 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 <= 1.5 x ULN
serum AST and ALT <= 2.5 x ULN (in case of liver metastases, then AST/ALT must be <= 5 x ULN)
serum creatinine <= 1.5 x ULN creatinine clearance >= 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)
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determination of the maximum tolerated dose (MTD) and dose-limiting toxicity<br /><br>(DLT) of sunitinib when given in combination with standard doses of ifosfamide.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the impact of sunitinib on ifosfamide pharmacokinetics and vice<br /><br>versa.<br /><br>To evaluate the impact of this combination on surrogate markers including VEGF<br /><br>and soluble VEGF-R plasma levels and the number of circulating endothelial<br /><br>cells (CECs)<br /><br>To record any disease response</p><br>