Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

Trial ID #	NCT00004037
Phase	II
Drug Class	Chemotherapy
Drug Name	Docetaxel
Alternate Drug Names	Taxotere
Drugs in Trial	Docetaxel
Eligible Participant	Platinum resistant or refractory ovarian cancer (after first-line platinum-based chemotherapy)
Patients Enrolled	60
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 22.4% (3CR, 10PR, n=58) DCR: 51.7% (3CR, 10PR, 17SD, n=58) DoR: 2.5 months (1.0-8.8) PFS: 2.1 months (0.5-26.2) OS: 12.7 months (1.9-38.1)
Clinically Significant Adverse Events	Serious AE: 1 treatment related death (neutropenia/neutropenic fever) Grade 3-4 AE: neutropenia (88.3%), leukopenia (66.7%)
Conclusion	Docetaxel shows activity, but with significant hematologic toxicity
Reference	Rose PG et al. A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol (2003) 88(2): 130-5 https://www.ncbi.nlm.nih.gov/pubmed/12586591