Clinical trial NCT00066742
Conditions: Limited Stage Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-09-01; Completion date: 2009-08-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: 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.
Interventions: intervention 1: tirapazamine intervention 2: cisplatin intervention 3: etoposide intervention 4: radiation therapy intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo radiation therapy intervention 5: Correlative studies

Protocol documents: