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
Date
2009
Authors
Ruff P.
Vorobiof D.A.
Jordaan J.P.
Demetriou G.S.
Moodley S.D.
Nosworthy A.L.
Werner I.D.
Raats J.
Burgess L.J.
Journal Title
Journal ISSN
Volume Title
Publisher
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. © 2009 Springer-Verlag.
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Keywords
docetaxel, placebo, zosuquidar, adjuvant chemotherapy, adult, aged, alanine aminotransferase blood level, anaphylaxis, anemia, article, aspartate aminotransferase blood level, breast cancer, cancer chemotherapy, cancer combination chemotherapy, cancer growth, cancer survival, clinical trial, combination chemotherapy, comparative study, controlled clinical trial, controlled study, dizziness, double blind procedure, drug efficacy, drug formulation, drug hypersensitivity, drug safety, drug storage, drug withdrawal, edema, fatigue, febrile neutropenia, female, gamma glutamyl transferase blood level, human, hyperglycemia, hypokalemia, hyponatremia, leukopenia, lymphocytopenia, major clinical study, metastasis, monotherapy, multicenter study, multiple cycle treatment, neutropenia, overall survival, paresthesia, peripheral edema, peripheral neuropathy, phase 2 clinical trial, priority journal, progression free survival, randomized controlled trial, recurrent cancer, sensory neuropathy, side effect, skin exfoliation, thrombocytopenia, treatment failure, treatment response, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Dibenzocycloheptenes, Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged, Neoplasm Metastasis, Placebos, Quinolines, Recurrence, Taxoids
Citation
Cancer Chemotherapy and Pharmacology
64
4
64
4