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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



Florida Hospital Cancer Institute Orlando, Florida  32804
Northeast Arkansas Clinic Jonesboro, Arkansas  72401-3125
Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Methodist Cancer Center Omaha, Nebraska  68114
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Hematology Oncology Life Center Alexandria, Louisiana  71301
Oncology Hematology Care Cincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and Research Lakeland, Florida  33805
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404