NCT00004014

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 liposomal doxorubicin in treating patients with 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

Enrollment
10

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 1999

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

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

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

September 14, 2004

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

9 months

First QC Date

November 1, 1999

Last Update Submit

August 13, 2010

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.

    Every 3 weeks, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter. Patients are followed every 3 months.

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG

Doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory prostate cancer Castrate serum testosterone levels less than 30 mg/dL occurring at least 4 weeks since prior flutamide or at least 6 weeks since prior bicalutamide Measurable or evaluable progressive disease Rising PSA involving two determinations (one at least 20 ng/mL if PSA is sole criterion) at least two weeks apart OR Increasing measurable or evaluable disease OR New metastasis PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatic insufficiency Renal: Creatinine no greater than 2.0 mg/dL No renal failure Cardiovascular: Cardiac ejection fraction at least 50% by radionuclide ventriculogram No myocardial infarction within the past year No active angina No congestive heart failure No arrhythmias requiring medication Other: No active peptic ulcers No uncontrolled infection or other serious medical condition that would prevent compliance with chemotherapy No uncontrolled diabetes No spinal cord compression or carcinomatous meningitis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy Concurrent gonadotropin-releasing hormone analogue allowed Radiotherapy: At least 2 months since prior radiotherapy (not to a measurable lesion) Concurrent palliative radiotherapy allowed Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cindy Connell, MD, PhD

    Ireland Cancer Center at University Hospitals/Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 14, 2004

Study Start

April 1, 1999

Primary Completion

January 1, 2000

Study Completion

November 1, 2001

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

US(1)