CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
carboplatin +1 moredrug
Likely dose
Paclitaxel 100 mg/m² on days 1, 8, 15 of each cycle; Carboplatin AUC 6 on day 1 of each cycleAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed adenocarcinoma of the prostate
  • ✓Metastatic disease with documented progression despite androgen ablation therapy
  • ✓Bidimensionally measurable disease or non-progressive bone metastases with rising PSA
  • ✓ECOG performance status less than 2
Key exclusion· 8
  • ✕Prior chemotherapy for prostate cancer
  • ✕Biochemical-only progression (no measurable disease)
  • ✕Decreasing PSA after antiandrogen withdrawal
  • ✕Grade ≥2 peripheral sensory or motor neuropathy

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

Search/NCT00049257
NCT00049257Phase 2Completed
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A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)

Jonsson Comprehensive Cancer Center·interventional·Posted Jan 27, 2003·Updated Sep 1, 2020

In Brief

A Phase 2 clinical trial evaluating carboplatin and paclitaxel for Prostate Cancer. Completed, enrolled 58 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 1, 2002
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 23.4 years ago

Interventions

carboplatindrug

Administered Day 1 of each cycle. AUC=6.

paclitaxeldrug

administered Days 1, 8, and 15 of each cycle. 100mg/m2