CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
ixabepilone +1 moredrug
Likely dose
Ixabepilone IV and pegylated liposomal doxorubicin IV (specific doses not stated in published record)AI-extracted
Key inclusion· 4
  • Histologically or cytologically confirmed advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer (Phase I and II) or metastatic breast cancer (Phase I only)
  • Platinum- and taxane-resistant disease with disease-free interval <6 months after completion of platinum- and taxane-based chemotherapy, or disease progression during the regimen (Phase II), or ≥2 prior regimens for metastatic breast cancer including 1 taxane-based regimen (Phase I)
  • Measurable or evaluable disease: unidimensionally measurable lesion, or CA 125 >50 U/mL on 2 occasions ≥1 week apart, or CA 27-29, CA 15-3, or CA 125 >50 U/mL on 2 occasions ≥1 week apart (breast cancer)
  • Life expectancy >3 months
Key exclusion· 6
  • Grade ≥2 neuropathy
  • Active brain metastases with evidence of cerebral edema, disease progression on prior imaging, requirement for steroids, or clinical symptoms
  • Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Ongoing or active infection

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

Search/NCT00182767
NCT00182767Phase 2Completed

A Phase I/II Study of BMS-247550 and Pegylated Liposomal Doxorubicin (Doxil®) in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane

National Cancer Institute (NCI)·interventional·Posted Sep 16, 2005·Updated Mar 10, 2016

In Brief

A Phase 2 clinical trial evaluating ixabepilone and pegylated liposomal doxorubicin hydrochloride for Fallopian Tube Cancer and 6 related conditions. Completed, enrolled 45 participants across 5 sites.

Detailed Summary

This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJan 1, 2006
Primary CompletionApr 1, 2012
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

ixabepilonedrug

Given IV

pegylated liposomal doxorubicin hydrochloridedrug

Given IV