A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed progressive metastatic or progressive
regional nodal adenocarcinoma of the prostate Regression of tumor following hormone
therapy If on antiandrogen therapy, must fail to respond to withdrawal or have progressive
disease following withdrawal of antiandrogen No CNS disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WCCC 0-2 Life expectancy:
At least 3 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least
1200/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin
no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Renal: Creatinine no
greater than 1.5 times upper limit of normal Other: At least 5 years since prior
malignancy other than: Inactive nonmelanoma skin cancer Adequately treated stage I or II
cancer in complete remission No other serious illness No spinal cord compression symptoms

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
required Endocrine therapy: Failed one secondary hormonal manipulation for metastatic
disease Concurrent testicular androgen suppression (LHRH) allowed No concurrent hormonal
therapy other than LHRH agonist At least 4 weeks since antiandrogen treatment in order to
evaluate for response withdrawal Radiotherapy: At least 4 weeks since prior radiation
therapy No prior strontium therapy Surgery: No prior orchiectomy Other: No concurrent
cholesterol lowering agents No concurrent supplemental vitamins No concurrent antioxidants