CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
bicalutamide +7 moredrug
Likely dose
Estramustine (oral), etoposide (oral), paclitaxel (intravenous), plus androgen-deprivation therapy (goserelin or leuprolide with bicalutamide, flutamide, or nilutamide)AI-extracted
Key inclusion· 4
  • Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
  • Clinical stage D2 disease evidenced by visceral disease (liver, lung, or other viscera) OR bone metastases in both axial (spine, pelvis, ribs, skull) and appendicular (claviculae, humeri, femora) skeleton
  • Age over 18 years
  • Zubrod performance status 0-2
Key exclusion· 10
  • Prior or concurrent (treated or untreated) brain metastases
  • Evidence of untreated spinal cord compression
  • Transient ischemic attack, stroke, or myocardial infarction within past 6 months
  • Active coronary artery disease requiring antianginal therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00028769
NCT00028769Phase 2Completed

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·interventional·Posted Jan 27, 2003·Updated Jul 16, 2013

In Brief

A Phase 2 clinical trial evaluating bicalutamide, estramustine, and 6 other interventions for Prostate Cancer. Completed, enrolled 41 participants across 91 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartDec 1, 2001
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 23.4 years ago

Interventions

bicalutamidedrug

estramustinedrug

etoposidedrug

flutamidedrug

goserelindrug

leuprolidedrug

nilutamidedrug

paclitaxeldrug