CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Carboplatin, Paclitaxel, and Bevacizumab given intravenouslyAI-extracted
Key inclusion· 7
  • Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, primary peritoneal carcinoma, or papillary serous mullerian carcinoma
  • Stage IC or greater
  • Previous attempted surgical debulking
  • Age 18 years or older
Key exclusion· 12
  • Prior chemotherapy or radiotherapy
  • Prior treatment with an anti-angiogenic agent
  • Inadequate surgical cytoreduction that could materially improve prognosis; no interval cytoreductive surgery permitted on study
  • Evidence of tumor involving major blood vessels on CT scan

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

Search/NCT00129727
NCT00129727Phase 2Completed

Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer

Massachusetts General Hospital·interventional·Posted Aug 12, 2005·Updated Jun 1, 2016

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 1 other intervention for Ovarian Cancer. Completed, enrolled 62 participants.

Detailed Summary

Study Design: This ia a Phase II study. Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited. Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21. Outcomes: Outcomes include toxicity, response rate, and progression free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
Countries--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2005
Enrollment StartJun 1, 2005
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.9 years ago

Interventions

Paclitaxeldrug

Given intravenously

Carboplatindrug

Given intravenously

Bevacizumabdrug

Given intravenously