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

Phase 2
18 Years
75 Years
Open (Enrolling)
Lung Cancer, Refractory to Chemotherapy

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Trial Information

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

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).

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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Principal Investigator

Eun Kyung Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

August 2007

Related Keywords:

  • Lung Cancer
  • Refractory to Chemotherapy
  • small-cell lung cancer
  • refractory
  • topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma