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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294190
• Other study ID #: SCRI LUN 120
• Secondary ID: 105642
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: December 6, 2012
• Start date: February 2006
• Est. completion date: July 2009

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Description:

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 weeks.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Topotecan
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.

Locations

Country	Name	City	State
United States	Hematology Oncology Life Center	Alexandria	Louisiana
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		18 months	No
Secondary	overall toxicity		18 months	No
Secondary	time to progression		18 months	No
Secondary	duration of response		18 months	No
Secondary	overall survival		18 months	No