Topotecan for Irinotecan-Refractory SCLC

Lung Cancer Clinical Trial

Official title:

Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00502762
• Other study ID #: GMO-LU-51
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: March 10, 2008
• Start date: September 2004
• Est. completion date: August 2007

Study information

• Verified date: March 2008
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Current commonly used second-line approaches for SCLC include re-induction with first-line therapy for chemosensitive disease, or single-agent topotecan. Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in a number of clinical studies, the choice of irinotecan as first-line therapy prevented use of the evidence-based option such as topotecan. Topotecan and irinotecan are cytotoxic agents that inhibit same intracellular pathway, namely topoisomerase I, which is an enzyme involved in DNA replication and RNA transcription.

Although their mechanism of action is similar, the preclinical and clinical data of these two drugs have some notable differences. Topotecan and irinotecan have different spectra of antitumor activity in various models of human cancer. Clinical data support that these agents may have different spectra of activity. The differences in antitumor activities may also reflect different mechanisms of resistance. Furthermore, topotecan and irinotecan have different limiting toxicities (myelosuppression and diarrhea, respectively).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Refractory to Chemotherapy
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate
Secondary	Safety