Lung Cancer Clinical Trial
Official title:
A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation
therapy in treating patients who have limited-stage small cell lung cancer.
OBJECTIVES:
- Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with
radiotherapy in patients with limited stage small cell lung cancer.
- Determine the toxicities of this treatment regimen in these patients.
- Determine the response rate in these patients treated with this regimen.
OUTLINE: Patients are assigned to one of two induction therapy arms.
- Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV
over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over
1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with
chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
- Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine,
cisplatin, etoposide, and radiotherapy as in arm I.
Patients with stable or responding disease then receive consolidation therapy consisting of
tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and
etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
Patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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