Back to resultsHigher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer, Carcinoma, Small Cell
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Lung Cancer, Extensive stage, Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Northeast Arkansas Clinic
- Florida Cancer Specialists
- Watson Clinic Center for Cancer Care and Research
- Florida Hospital Cancer Institute
- Northeast Georgia Medical Center
- Consultants in Blood Disorders and Cancer
- Hematology Oncology Life Center
- Grand Rapids Clinical Oncology Program
- Methodist Cancer Center
- Oncology Hematology Care
- Spartanburg Regional Medical Center
- Chattanooga Oncology Hematology Associates
- Tennessee Oncology, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topotecan
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
overall toxicity
time to progression
duration of response
overall survival
Full Information
NCT ID
NCT00294190
First Posted
February 16, 2006
Last Updated
December 6, 2012
Sponsor
SCRI Development Innovations, LLC
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00294190
Brief Title
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Official Title
A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Carcinoma, Small Cell
Keywords
Lung Cancer, Extensive stage, Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
18 months
Secondary Outcome Measure Information:
Title
overall toxicity
Time Frame
18 months
Title
time to progression
Time Frame
18 months
Title
duration of response
Time Frame
18 months
Title
overall survival
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spigel, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Arkansas Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Watson Clinic Center for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Hematology Oncology Life Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21663862
Citation
Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.
Results Reference
derived
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Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
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