Topotecan for Irinotecan-Refractory SCLC

March 10, 2008 updated by: Gachon University Gil Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 405 760
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Eun Kyung Cho, MD, Gachon University Gil Medical Center, Incheon, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (ANTICIPATED)

August 1, 2007

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (ESTIMATE)

July 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMO-LU-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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