Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer
|Fallopian Tube Cancer Female Reproductive Cancer Recurrent Breast Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Breast Cancer Stage IV Ovarian Epithelial Cancer||Drug: ixabepilone Drug: pegylated liposomal doxorubicin hydrochloride||Phase 1 Phase 2|
|Study Design:||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|
- 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 ]Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities
- Maximum Tolerated Dose [ Time Frame: Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD). ]The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details
- 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 ]
- Progression-free Survival [ Time Frame: The time from start of treatment to time of progression or death, assessed up to 2 years ]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)
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
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|