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A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer, Carcinoma, Small Cell

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Trial Information

A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

All patients will receive weekly topotecan.

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are
repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8

Inclusion Criteria:

- Extensive small cell lung cancer with progression after one previous chemotherapy or
chemotherapy/radiation therapy regimen

- Measurable or evaluable disease

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, liver and kidney function

- May have received no more than 3 previous courses of radiation therapy

- Give written informed consent prior to study entry

Exclusion Criteria:

- Patients with limited stage disease

- History of a prior malignancy within three years

- Female patients who are pregnant or are breast feeding

- Significant history of uncontrolled cardiac disease

- Myocardial infarction or stroke within six months

- Symptomatic peripheral vascular disease

- CNS involvement

- Serious active infection or underlying medical condition

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:

Overall response rate

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

July 2009

Related Keywords:

  • Small Cell Lung Cancer
  • Carcinoma, Small Cell
  • Lung Cancer
  • Extensive stage
  • Small Cell Lung Cancer
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell



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