NCT00028769|CompletedPhase 2Results

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000069132S0032U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedDec 2001

CompletionJul 2011

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline

Completed

Started Dec 2001

Longer than P75 for phase_2 prostate-cancer

Geographic Reach

1 country

91 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

9.6 years study duration

Study Start

First participant enrolled

December 1, 2001

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed

1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

2 years until next milestone

Results Posted

Study results publicly available

July 16, 2013

Completed

Last Updated

July 16, 2013

Status Verified

June 1, 2013

Enrollment Period

8.5 years

First QC Date

January 4, 2002

Results QC Date

November 15, 2012

Last Update Submit

June 12, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

Progression-free Survival
Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)
Overall Survival (OS)
Overall survival is defined from the date of registration to date of death from any cause
0-5 years

Secondary Outcomes (1)

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
up to 5 years after registration

Study Arms (1)

Hormone therapy, estramustine, etoposide and paclitaxel

EXPERIMENTAL

Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel

Drug: bicalutamideDrug: estramustineDrug: etoposideDrug: flutamideDrug: goserelinDrug: leuprolideDrug: nilutamideDrug: paclitaxel