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Topotecan for Irinotecan-Refractory SCLC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Gachon University Gil Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502762
First Posted: July 18, 2007
Last Update Posted: March 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gachon University Gil Medical Center
  Purpose

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.


Condition Intervention Phase
Lung Cancer Refractory to Chemotherapy Drug: topotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Safety

Study Start Date: September 2004
Estimated Study Completion Date: August 2007
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502762


Locations
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Eun Kyung Cho, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

ClinicalTrials.gov Identifier: NCT00502762     History of Changes
Other Study ID Numbers: GMO-LU-51
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: March 12, 2008
Last Verified: March 2008

Keywords provided by Gachon University Gil Medical Center:
small-cell lung cancer
refractory
topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action