Phase I Trial of ADI-PEG 20 Plus Docetaxel in Advanced Solid Tumors With Emphasis on Castration Resistant Prostate Cancer (CRPC)
- 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
- 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
- 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.
- 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.