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

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00294190
Collaborator
GlaxoSmithKline (Industry)
38
Enrollment
13
Locations
1
Arm
40.9
Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.)

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topotecan

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [18 months]

    Secondary Outcome Measures

    1. overall toxicity [18 months]

    2. time to progression [18 months]

    3. duration of response [18 months]

    4. overall survival [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Northeast Arkansas Clinic Jonesboro Arkansas United States 72401
    2 Florida Cancer Specialists Fort Myers Florida United States 33901
    3 Watson Clinic Center for Cancer Care and Research Lakeland Florida United States 33805
    4 Florida Hospital Cancer Institute Orlando Florida United States 32804
    5 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    6 Consultants in Blood Disorders and Cancer Louisville Kentucky United States 40207
    7 Hematology Oncology Life Center Alexandria Louisiana United States 71301
    8 Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    9 Methodist Cancer Center Omaha Nebraska United States 68114
    10 Oncology Hematology Care Cincinnati Ohio United States 45242
    11 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    12 Chattanooga Oncology Hematology Associates Chattanooga Tennessee United States 37404
    13 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00294190
    Other Study ID Numbers:
    • SCRI LUN 120
    • 105642
    First Posted:
    Feb 20, 2006
    Last Update Posted:
    Dec 10, 2012
    Last Verified:
    May 1, 2011
    Keywords provided by SCRI Development Innovations, LLC
    Lung Cancer
    Extensive stage
    Small Cell Lung Cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Carcinoma, Small Cell
    Topotecan

    Study Results

    No Results Posted as of Dec 10, 2012