Topotecan for Irinotecan-Refractory SCLC

NCT ID: NCT00502762

Last Updated: 2008-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-08-31

Brief 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.

Detailed 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).

Conditions

Lung Cancer; Refractory to Chemotherapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

topotecan

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Eun Kyung Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center, Incheon, Korea

Locations

Gachon University Gil Medical Center

Incheon, , South Korea

Countries

South Korea

Other Identifiers

GMO-LU-51

Identifier Type: -

Identifier Source: org_study_id