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 platinum-resistant and platinum-refractory patients

Reference

Markmann 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: 436-440
https://www.ncbi.nlm.nih.gov/pubmed/16325893