A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Trial ID #	NCT00023907
Phase	II
Drug Class	Chemotherapy
Drug Name	Paclitaxel
Alternate Drug Names	Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial	Paclitaxel
Eligible Participant	Platinum resistant or refractory ovarian cancer (after first-line platinum-based chemotherapy)
Patients Enrolled	51
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, evaluated per RECIST
Efficacy	Weekly paclitaxel: ORR: 20.9% (2CR, 8 PR, n=48) DCR: 45.8% (2CR, 8PR, 22SD, n=48) DoR: 3.6 months
Clinically Significant Adverse Events	Serious AE; Grade 3-4 AE: 25% neurotoxicity, mostly low grade
Conclusion	Weekly paclitaxel shows promising activity in Pt-R and Pt-Rf patients
Reference	Markmann M et al. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol (2006) 101(3): 436-40 https://www.ncbi.nlm.nih.gov/pubmed/16325893