Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer

Inclusion Criteria:

• For the phase I portion patients must have cytologically or histologically proven advanced malignant solid tumors, with emphasis on castrate resistant prostate cancer. For the expansion phase, patients must have castrate resistant prostate cancer.
• 18 years of age or older.
• Zubrod (ECOG) performance status of 0-2.
• Estimated survival of at least 3 months.
• Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. Prior radiation must have been completed at least 2 weeks prior to start of therapy.
• Radiographs (Xrays, CT scans, etc.) to follow disease response or progression must have been completed within 28 days prior to registration.
• Adequate renal function: calculated creatinine clearance of > 45 ml/min.
• Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, and bilirubin < upper limit of normal.
• Adequate bone marrow function: Platelets >100,000 cells/mm3 and ANC > 1,500 cells/mm3.
• Must not have ≥ Grade 2 symptomatic sensory neuropathy.
• Must not have a history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Clinically significant concurrent illness.
• Currently enrolled in a different clinical study.
• History of allergy or hypersensitivity to the study drug or a taxane.
• Prior therapy with ADI-PEG 20 or docetaxel.
• Allergy to pegylated compounds.