Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors
may be in combination with chemotherapy. The optimal use of atrasentan may be in combination
with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube
cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity
profile, ease of administration, and activity in both platinum sensitive as well as
platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women
with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane
therapy.
PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd
line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or
peritoneal cancer.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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