Trial | NCT00193401  Report issue

Title

Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    topotecan ...

  • Study Participants

    40
In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens
Upon determination of eligibility, all patients will be receive:

Topotecan
Study Started
Aug 31
2002
Primary Completion
Jun 30
2004
Study Completion
Nov 30
2004
Last Update
Jul 28
2010
Estimate

Drug Topotecan

Criteria 

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Biopsy-proven small cell lung cancer, extensive stage disease
Age > 65 years
No previous chemotherapy or radiation therapy.
Measurable or evaluable disease.
Adequate bone marrow, liver and kidney function.
Must be > 4 weeks from previous major surgery
Must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Meningeal involvement
Serious active infections
Serious underlying medical conditions
Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
No Results Posted