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

• DOI: 10.1007/s00280-009-0925-9
• Publication Date: 2009-02-24T19:53:12Z
• 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
• Keywords: double blind procedure; drug safety; peripheral neuropathy; hyponatremia; peripheral edema; Docetaxel; Placebos; 0302 clinical medicine; Recurrence; Antineoplastic Combined Chemotherapy Protocols; docetaxel; Neoplasm Metastasis; cancer survival; comparative study; combination chemotherapy; adult; article; clinical trial; Middle Aged; anemia; 3. Good health; adjuvant chemotherapy; aged; female; drug withdrawal; monotherapy; Quinolines; Female; Taxoids; Adult; overall survival; 610; Breast Neoplasms; Dibenzocycloheptenes; cancer chemotherapy; cancer growth; Disease-Free Survival; multiple cycle treatment; paresthesia; 03 medical and health sciences; breast cancer; Double-Blind Method; cancer combination chemotherapy; 616; anaphylaxis; hypokalemia; metastasis; neutropenia; Humans; controlled study; human; dizziness; Aged; controlled clinical trial; leukopenia; zosuquidar; major clinical study; drug efficacy; drug formulation; febrile neutropenia; multicenter study; lymphocytopenia; placebo; drug storage; fatigue; hyperglycemia; aspartate aminotransferase blood level; gamma glutamyl transferase blood level; edema; alanine aminotransferase blood level; drug hypersensitivity

To determine if concomitant administration of docetaxel plus zosuquidar.3HC1 can prolong progression-free survival in patients with metastatic breast cancer.A randomized, double-blind, multicenter, placebo-controlled clinical trial comparing docetaxel plus 500 mg zosuquidar.3HCl (DZ) with docetaxel plus placebo (DP).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.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.