NCT00502762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

First QC Date

July 16, 2007

Last Update Submit

March 10, 2008

Conditions

Lung CancerRefractory to Chemotherapy

Keywords

small-cell lung cancerrefractorytopotecan

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (1)

  • Safety

Interventions

topotecanDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405 760, South Korea

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Eun Kyung Cho, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

September 1, 2004

Study Completion

August 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

KR(1)