CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Thalidomide +1 moredrug
Likely dose
Thalidomide 100 mg orally daily with escalation by 50 mg every 4 weeks to maximum 200 mg daily, plus liposomal doxorubicin 40 mg/m² IV over 1 hour every 28 daysAI-extracted
Key inclusion· 10
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate
  • ✓Androgen-independent prostate cancer with evidence of rising PSA (two successive increases at least 4 weeks apart) while on chemotherapy, with castrate testosterone levels <50 ng/ml
  • ✓No more than 2 previous chemotherapy regimens
  • ✓Age >18 years
Key exclusion· 4
  • ✕Unstable angina, uncompensated CHF, history of MI, PE or DVT within last 3 months
  • ✕Anthracycline therapy within past 6 months
  • ✕Prior single-agent thalidomide within past 12 months
  • ✕Prior cytotoxic chemotherapy given in conjunction with thalidomide

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

Search/NCT00307294
NCT00307294Phase 2Completed
CompareCT.gov

Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy

University of Pittsburgh·interventional·Posted Mar 27, 2006·Updated Nov 24, 2017

In Brief

A Phase 2 clinical trial evaluating Thalidomide and Doxil for Prostate Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsOrtho Biotech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2006
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.3 years ago

Interventions

Thalidomidedrug

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Doxildrug

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days