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


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

Thank you

Trial Information

Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With 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:

- 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.

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 65

NCT ID:

NCT00193401

Start Date:

August 2002

Completion Date:

November 2004

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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