A Phase II Study of Atrasentan (ABT-627) Plus DOXIL in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy
OBJECTIVES:
Primary
- To determine the median time to tumor progression in patients with recurrent ovarian
epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary
adenocarcinoma treated with Doxil and atrasentan hydrochloride.
Secondary
- To determine the objective response rate and survival of patients treated with this
regimen.
- To determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
treatment with platinum-taxane (sensitive vs resistant).
Patients will be administered Doxil 50 mg/m2 intravenous every 28 days and take atrasentan
10 mg orally everyday continuously beginning on Day 1. Patients will continue Doxil +
atrasentan in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and every 2 months
thereafter.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Time to Tumor Progression
Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
Date on study to the date of measured progressive disease, every 2 cycles (2 months)
No
Marta Crispens, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GYN 0288
NCT00653328
May 2003
March 2009
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Jackson-Madison County Hospital | Jackson, Tennessee 38301 |
St. Thomas Health Services | Nashville, Tennessee 37205 |
Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
The Jones Clinic | Germantown, Tennessee 38138 |
Central Georgia Hematology Oncology Associates, P.C. | Macon, Georgia |