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


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


OBJECTIVES: I. Evaluate the clinical effectiveness of oral perillyl alcohol given to
patients with androgen independent metastatic prostate cancer. II. Assess the toxicity of
this treatment in these patients.

OUTLINE: Patients receive oral perillyl alcohol 4 times a day for 4 weeks. Patients continue
treatment in the absence of severe toxicity and disease progression. Patients are followed
every 3 months for survival after disease progression.

PROJECTED ACCRUAL: This study will accrue 20-40 patients in approximately 2 years.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

George Wilding, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000066113

NCT ID:

NCT00003238

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Leonard C. Ferguson Cancer CenterFreeport, Illinois  61032
Green Bay Oncology, Ltd.Green Bay, Wisconsin  54307-3453
Mercy Health SystemJanesville, Wisconsin  53545
Meriter HospitalMadison, Wisconsin  53715
Sinai Samaritan Medical Center - MilwaukeeMilwaukee, Wisconsin  53201-0342
North Central Oncology Associates, S.C.Wausau, Wisconsin  54401