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Phase II Trial of Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial of Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer


Upon determination of eligibility, all patients will be receive:

- Topotecan


Inclusion Criteria:



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

- Small Cell Lung cancer

- Progression after one previous regimen

- Measurable or evaluable disease

- Able to perform activities of daily living with assistance

- Adequate bone marrow, liver and kidney function

- No more than three previous courses of radiation therapy

- Accessible for treatment and follow up

- 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:

- Central nervous system involvement

- Serious or active infection

- Serious underlying medical condition

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Principal Investigator

Anthony Greco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 66

NCT ID:

NCT00193388

Start Date:

September 2002

Completion Date:

February 2007

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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