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

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Cancer Carcinoma, Small Cell	Drug: Topotecan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	February 2006
Study Completion Date:	July 2009
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Topotecan	Drug: Topotecan Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Other Name: Hycamtin

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.)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294190

Locations

United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Hematology Oncology Life Center
Alexandria, Louisiana, United States, 71301
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

Sarah Cannon Research Institute

GlaxoSmithKline

Investigators

Principal Investigator:

David R. Spigel, MD

Sarah Cannon Research Institute

More Information

No publications provided by Sarah Cannon Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Apr 28.

Responsible Party:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00294190 History of Changes
Other Study ID Numbers:	SCRI LUN 120, 105642
Study First Received:	February 16, 2006
Last Updated:	December 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:

Lung Cancer
Extensive stage
Small Cell Lung Cancer

Additional relevant MeSH terms:

Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013