This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.
University of California at Davis
Sacramento, California, United States
Number of Participants with Adverse Events
Time frame: 6 months
Efficacy, as determined by objective response measures
Time frame: 6 months
Determine the maximum tolerated dose (MTD) of ADI-PEG 20 with docetaxel
Time frame: 6 months
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