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
- 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.
- To determine the objective response rate and survival of patients treated with this
- 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
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)
Marta Crispens, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GYN 0288
|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|