drugset / Trial / NCT00653328

Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma

NCT00653328

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2003-05
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Atrasentan Other / unclassified 10 mg Oral
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous