CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
bevacizumab +1 moredrug
Likely dose
Erlotinib 150 mg orally daily; bevacizumab 10 mg/kg IV every two weeksAI-extracted
Key inclusion· 9
  • ✓Histologically or pathologically confirmed epithelial ovarian carcinoma or primary peritoneal carcinoma.
  • ✓Relapsed within 6 months after prior platinum/taxane therapy, or with stable disease during ≤2 prior chemotherapy regimens (may include up to 2 additional chemotherapy regimens beyond the primary regimen).
  • ✓Up to one year of consolidation IP/IV chemotherapy allowed if used to consolidate complete remission.
  • ✓Elevated CA-125 (>2× institutional upper limit of normal) or RECIST-measurable disease required.
Key exclusion· 13
  • ✕Mixed mullerian tumors and borderline ovarian tumors (except borderline tumors that evolved into higher-grade tumors).
  • ✕Chemotherapy, biologic therapy, or investigational drug within 28 days prior to start of therapy (must recover to grade 1 or less, except alopecia).
  • ✕Baseline systolic/diastolic blood pressure >150/100 mmHg; must be controlled with antihypertensive therapy.
  • ✕NYHA Grade II or greater congestive heart failure.

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

Search/NCT00130520
NCT00130520Phase 2Completed
CompareCT.gov

Phase II Open-Label Trial of Erlotinib (Tarceva) and Bevacizumab in Women With Advanced Ovarian Cancer

University of Arizona·interventional·Posted Aug 15, 2005·Updated May 28, 2012

In Brief

A Phase 2 clinical trial evaluating bevacizumab and erlotinib for Ovarian Neoplasms. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionJan 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.9 years ago

Interventions

bevacizumabdrug

10mg/kg every two weeks IV-bevacizumab

erlotinibdrug

150mg daily by mouth-erlotinib