A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer
- Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel,
carboplatin, and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell
- Determine, preliminarily, the response rate and survival of patients treated with this
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of tirapazamine.
Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and
carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1
hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Beginning on day 1, patients
undergo radiotherapy once daily 5 days a week for 6.5 weeks. Beginning 4-5 weeks after
completion of radiotherapy, patients with stable or responding disease receive consolidation
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
days 1 and 22.
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Primary Purpose: Treatment
Derick H. Lau, MD
University of California, Davis
United States: Federal Government
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|