CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Erlotinib + Bevacizumabdrug
Likely dose
Erlotinib daily for 24 weeks and bevacizumab every 3 weeks for 8 dosesAI-extracted
Key inclusion· 7
  • ✓Karnofsky performance status >80
  • ✓Localized, organ-confined prostate cancer with radical prostatectomy completed and node-negative disease confirmed
  • ✓High-risk disease defined as pre-RP PSA >15 ng/dL, Gleason >8, Stage T3, or positive surgical margins
  • ✓Adequate bone marrow function: ANC >1500/mm³, hemoglobin >9.0 g/dL, platelets >100,000/mm³
Key exclusion· 12
  • ✕Evidence of metastatic disease
  • ✕Prior immunotherapy, biological therapy, hormonal therapy, or radiation therapy for prostate cancer
  • ✕Active secondary malignancies (other than basal cell carcinoma of skin)
  • ✕Serious, nonhealing wound, ulcer, or bone fracture

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

Search/NCT00203424
NCT00203424Phase 2Completed
CompareCT.gov

A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer

Translational Oncology Research International·interventional·Posted Sep 20, 2005·Updated Mar 25, 2016

In Brief

A Phase 2 clinical trial evaluating Erlotinib + Bevacizumab for Prostate Cancer. Completed, enrolled 23 participants across 16 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Erlotinib + Bevacizumabdrug

Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses