A randomized, placebo-controlled, double-blind phase 2 study of docetaxel compared to docetaxel plus zosuquidar (LY335979) in women with metastatic or locally recurrent breast cancer who have received one prior chemotherapy regimen.

Abstract

PURPOSE:

To determine if concomitant administration of docetaxel plus zosuquidar.3HC1 can prolong progression-free survival in patients with metastatic breast cancer.

METHODS:

A randomized, double-blind, multicenter, placebo-controlled clinical trial comparing docetaxel plus 500 mg zosuquidar.3HCl (DZ) with docetaxel plus placebo (DP).

RESULTS:

A total of 170 patients were enrolled and randomly assigned to treatment. The median age was 53 years (range, 31-74 years). 81.7% of patients had prior chemotherapy in the adjuvant setting and 18.3% in the neoadjuvant setting. The median progression-free survival time was statistically different between groups [7.2 months (DZ) vs. 8.3 months (DP)]. Once the stratification factor relative to progression following prior chemotherapy was considered, no significant treatment difference existed.

CONCLUSION:

The combination of zosuquidar.3HCl plus docetaxel is safe. The analysis of efficacy data is complex, but it can be concluded that there is no difference in progression-free survival, overall survival, or response rate in the study as a whole.

• Authors: Paul Ruff, D A Vorobiof, J P Jordaan, G S Demetriou, S D Moodley, A L Nosworthy, I D Werner, J Raats, L J Burgess
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 64 Issue 4 Pg. 763-8 (Sep 2009) ISSN: 1432-0843 [Electronic] Germany
• PMID: 19241078 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Dibenzocycloheptenes
• Placebos
• Quinolines
• Taxoids
• Docetaxel
• zosuquidar trihydrochloride

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Dibenzocycloheptenes (administration & dosage)
• Disease-Free Survival
• Docetaxel
• Double-Blind Method
• Female
• Humans
• Middle Aged
• Neoplasm Metastasis
• Placebos
• Quinolines (administration & dosage)
• Recurrence
• Taxoids (administration & dosage)