NCT00004045

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1999

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

2 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

June 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

April 15, 2004

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

December 10, 1999

Last Update Submit

May 15, 2012

Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate cancer

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma Metastatic disease Documented progression of prostate cancer while receiving androgen ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3 occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA must be above 20 ng/mL prior to study entry No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Fertile patients must use effective contraception No uncontrolled pain requiring irradiation No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or incompetence PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g., flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal preparations (e.g., PC-SPES)

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

Sponsors & Collaborators

Study Sites (2)

U.S. Oncology Research Inc.

Houston, Texas, 77060, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245-3217, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

exatecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 10, 1999

First Posted

April 15, 2004

Study Start

June 1, 1999

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(2)