NCT00003238

Brief Summary

RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

July 21, 2004

Completed
Last Updated

December 13, 2019

Status Verified

August 1, 2013

Enrollment Period

3.7 years

First QC Date

November 1, 1999

Last Update Submit

December 12, 2019

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Interventions

perillyl alcoholDRUG

Eligibility Criteria

AgeUp to 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Leonard C. Ferguson Cancer Center

Freeport, Illinois, 61032, United States

Location

Green Bay Oncology, Ltd.

Green Bay, Wisconsin, 54307-3453, United States

Location

Mercy Health System

Janesville, Wisconsin, 53545, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Sinai Samaritan Medical Center - Milwaukee

Milwaukee, Wisconsin, 53201-0342, United States

Location

North Central Oncology Associates, S.C.

Wausau, Wisconsin, 54401, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perillyl alcohol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • George Wilding, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 21, 2004

Study Start

February 1, 1998

Primary Completion

October 1, 2001

Last Updated

December 13, 2019

Record last verified: 2013-08

Locations

US(8)