Trial Information

A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide

OBJECTIVES:

Primary

- Evaluate the response frequency of patients with extensive stage small cell lung cancer
treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and
etoposide.

- Evaluate the toxic effects of these regimens in these patients.

- Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

- To investigate the occurrence of various breast cancer resistance protein (BCRP)
alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical
response and toxicity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (PET): Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3;
etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on
days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and
continuing until blood counts recover.

- Arm II (PIE): Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60
minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 140 patients were accrued for this study.