Must have histologically or cytologically confirmed adenocarcinoma consistent clinically
and histologically with carcinoma of the prostate Confirmed androgen independent prostate
cancer (progression despite castrate levels of serum testosterone) Measurable or evaluable
disease (PSA elevation will constitute evaluable disease) 18 years of age. Because no
dosing or adverse event data are currently available on the use of oxaliplatin in patients
< 18 years of age, they are excluded from this study.
Life expectancy of greater than 3 months. ECOG Performance status of 0-1. No more than 2
prior regimens of cytotoxic chemotherapy. Androgen deprivation (castration or LHRH
analogue), and prior antiandrogens allowed.
Patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28
Concurrent bisphosphonate therapy allowed. Patients with prior radiotherapy for treatment
of their bony metastases will be included if time since radiation is > 4 weeks, and if PSA
is clearly rising.
Patients must have acceptable organ function as defined as: :WBC > 2500/mm3 or ANC >
1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3; Bilirubin < 1.5 mg/dL,
SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present), PT/PTT normal; Creatinine <
1.8 mg/dL Adequate neurologic function defined as no clinically significant peripheral
neuropathy, defined as any neuropathy ≤ grade 1.
Adequate cardiovascular function defined as no active congestive heart failure, no
uncontrolled angina, no myocardial infarction within the past 6 months.
No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. May
not be taking other investigational drugs while on trial.
Patients with known brain metastases should be excluded from this clinical trial because
of their poor prognosis and because they often develop progressive neurologic dysfunction
that would confound the evaluation of neurologic and other adverse events.
No prior therapy with oxaliplatin is allowed. No history of allergic reactions attributed
to the drugs used in this study or compounds of similar chemical or biologic composition.
No history of intolerance or allergy to the antiemetics to be administered in conjunction
with the study drugs (i.e., 5 HT3 antagonists).
No concurrent other active cancer from another primary site, except squamous cell and
basal cell carcinoma of the skin.
No other serious concomitant illness will be allowed, including interstitial pneumonia,
extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable
angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac
arrhythmia, uncontrolled diabetes mellitus or active infection.