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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00294190
First received: February 16, 2006
Last updated: December 6, 2012
Last verified: May 2011
  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:


Further study details as provided by SCRI Development Innovations, LLC:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
SCRI Development Innovations, LLC
GlaxoSmithKline
Investigators
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
  More Information

No publications provided by SCRI Development Innovations, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SCRI Development Innovations, LLC
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 SCRI Development Innovations, LLC:
Lung Cancer
Extensive stage
Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Small Cell
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
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 August 28, 2014