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: 130-135
https://www.ncbi.nlm.nih.gov/pubmed/12586591