Ixabepilone and Liposomal Doxorubicin in Treating Women With Advanced Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer or Metastatic Breast Cancer
Fallopian Tube Cancer
Female Reproductive Cancer
Primary Peritoneal Cavity Cancer
Recurrent Breast Cancer
Recurrent Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Breast Cancer
Stage IV Ovarian Epithelial Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose (MTD) of ixabepilone, determined according to incidence of dose-limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Proportion of patients responding to therapy (complete response [CR], partial response [PR], or stable disease [SD]), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) and cancer antigen-125 (CA-125) response criteria (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: The time from start of treatment to time of progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]We will summarize progression-free survival by Kaplan-Meier survival analysis.
|Study Start Date:||January 2006|
|Study Completion Date:||May 2014|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ixabepilone and doxorubicin hydrochloride)
Patients receive ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
Other Names:Drug: pegylated liposomal doxorubicin hydrochloride
Other Names:Other: pharmacological study
Other Name: pharmacological studies
I. To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride (HCl) liposome (pegylated liposomal doxorubicin hydrochloride) in women with previously treated advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.
II. To determine the safety profile of this regimen in these patients. III. To determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
OUTLINE: This is a phase I, multicenter, open-label, dose-escalation study of ixabepilone followed by a phase II study.
Patients receive ixabepilone intravenously (IV) over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182767
|United States, Connecticut|
|University of Connecticut|
|Farmington, Connecticut, United States, 06030|
|United States, New York|
|Women's Cancer Care Associates LLC|
|Albany, New York, United States, 12208|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467-2490|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|Principal Investigator:||Ellen Chuang||Montefiore Medical Center - Moses Campus|