Annals of Oncology 14:543-548, 2003
© 2003 European Society for Medical Oncology
Original Paper |
A phase II study of ZD0473 given as a short infusion every 3 weeks to patients with advanced or metastatic breast cancer: a National Cancer Institute of Canada Clinical Trials Group trial, IND 129
1 British Columbia Cancer Agency-Vancouver Cancer Center, Vancouver, BC; 2 London Regional Cancer Center, London, ON; 3 Jewish General Hospital, McGill, Montreal, PQ; 4 British Columbia Cancer Agency-Fraser Valley Cancer Center, Surrey, BC; 5 University Health Network, Ontario Cancer Institute/Princess Margaret Hospital, Toronto, ON; 6 AstraZeneca Canada, Mississauga, ON; 7 National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada
Received 29 July 2002; revised 12 December 2002; accepted 14 January 2003
Background:
ZD0473 is a new generation platinum compound with activity against a wide range of human tumor cell lines and xenografts, including carboplatin- and cisplatin-resistant lines. A phase II study of ZD0473 in advanced breast cancer was initiated by the National Cancer Institute of Canada Clinical Trials Group.
Patients and methods:
Women with metastatic breast cancer, measurable disease, an Eastern Cooperative Oncology Group performance status of up to two, and a maximum of one prior cytotoxic agent for recurrent disease were enrolled and treated at 120 mg/m2 every 3 weeks. After 13 patients were enrolled, the dose was increased to 150 mg/m2 on the basis of emergent data from studies ongoing at the time.
Results:
Thirty-three women were evaluable for toxicity and 26 patients for response. Toxicity was mainly hematological with grade 3/4 thrombocytopenia in 12 of 20 patients (60%) treated at 150 mg/m2 and grade 3 thrombocytopenia in three of 13 patients (23%) at 120 mg/m2. Grade 3/4 neutropenia occurred in 15 patients (75%) at 150 mg/m2 and two patients (10%) at 120 mg/m2. Non-hematological toxicities were generally mild or moderate. There was one partial response seen for a response rate of 3.8% (95% confidence interval 0.1% to 19.5%) and stable disease in 15 patients.
Conclusion:
ZD0473 has minor activity as a single agent in metastatic breast cancer. Combinations with other drugs including docetaxel are ongoing and may be of interest.
Key words: breast cancer, phase II studies, platinum, ZD0473
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  K. A. Gelmon, D. Stewart, K. N. Chi, S. Chia, C. Cripps, S. Huan, S. Janke, D. Ayers, D. Fry, J. A. Shabbits, et al. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131 Ann. Onc., July 1, 2004; 15(7): 1115 - 1122. [Abstract] [Full Text] [PDF]
|
|