Topotecan for Irinotecan-Refractory SCLC

• Status: Unknown status
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in phase II/III clinical trials, the choice of irinotecan as first-line therapy prevented use of the evidence-based option.

This pilot study will be conducted to determine the activity and safety of topotecan in SCLC patients refractory to first-line therapy with irinotecan and platinum.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Treatments: Irinotecan; Topotecan

Criteria

Inclusion Criteria:

• histologically or cytologically proven SCLC

• refractory to prior irinotecan-based chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

• age between 18 and 75 years

• no active brain or leptomeningeal metastases

• adequate hematologic, hepatic and renal functions

• at least one measurable lesion(s)

Exclusion Criteria:

• pregnant or lactating women

• patients with active infection

• extensive radiotherapy within the previous 4 weeks

• previous other malignancies with the exception of adequately treated non-melanoma skin cancer or in situ cervical cancer

• any severe comorbid illness

• a known history of anaphylaxis of any origin

• history of severe adverse events to the drug used in this study