NCT00066742

Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer

A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess overall survival in patients with limited stage small cell lung cancer (SCLC) treated with induction tirapazamine combined with cisplatin, etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide. II. To assess time to treatment failure calculated from initiation of step 1, response (confirmed plus unconfirmed, complete plus partial during induction in the subset of patients with measurable disease) and toxicity in this patient population treated with this regimen. III. To investigate in an exploratory manner the association of baseline PAI-1, VEGF, OPN and NDRG1 plasma markers with patient response and survival. OUTLINE: This is a multicenter study. CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; 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. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks. CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.

Conditions

• Limited Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	tirapazamine	Given IV
DRUG	cisplatin	Given IV
DRUG	etoposide	Given IV
RADIATION	radiation therapy	Undergo radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2003-08-07
• Last updated: 2014-05-15
• Results posted: 2012-07-19

Locations

1 site across 1 country: United States