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Topotecan for Irinotecan-Refractory SCLC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Gachon University Gil Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00502762
First received: July 16, 2007
Last updated: March 10, 2008
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00502762     History of Changes
Other Study ID Numbers: GMO-LU-51
Study First Received: July 16, 2007
Last Updated: March 10, 2008
Health Authority: Korea: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013