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The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00043862
Collaborator
(none)
60
Enrollment
31
Locations
1.9
Patients Per Site

Study Details

Study Description

Brief Summary

This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer
Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Response rate []

Secondary Outcome Measures

  1. Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability []

Eligibility Criteria

Criteria

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

  • Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.

  • Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.

  • Patients must give written informed consent to participate in the study.

  • Patients must be able to take oral medication.

  • Patients should be completely recovered from recent surgery.

  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

  • Patients must be evaluated by the radiation oncologist prior to study entry.

Exclusion Criteria:

  • Extensive Stage SCLC.

  • Women who are pregnant or lactating.

  • Use of an investigational drug within 30 days prior to the first dose of study medication.

  • Any medically/clinically significant active infection.

  • Symptoms of the SCLC spreading to the brain.

  • Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.

  • Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.

  • Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Phoenix Arizona United States 85013 - 4496
2 GSK Investigational Site Little Rock Arkansas United States 72205
3 GSK Investigational Site Bakersfield California United States 93309
4 GSK Investigational Site Fountain Valley California United States 92708
5 GSK Investigational Site Los Angeles California United States 90057
6 GSK Investigational Site Gainesville Florida United States 32610
7 GSK Investigational Site Indianapolis Indiana United States 46260
8 GSK Investigational Site Lexington Kentucky United States 40536-0098
9 GSK Investigational Site New Orleans Louisiana United States 70112
10 GSK Investigational Site New Orleans Louisiana United States 70121
11 GSK Investigational Site Shreveport Louisiana United States 71103
12 GSK Investigational Site Scarborough Maine United States 04074
13 GSK Investigational Site Springfield Massachusetts United States 01107
14 GSK Investigational Site Duluth Minnesota United States 55805
15 GSK Investigational Site Minneapolis Minnesota United States 55455
16 GSK Investigational Site Robbinsdale Minnesota United States 55422
17 GSK Investigational Site Saint Louis Missouri United States 63141
18 GSK Investigational Site St. Louis Montana United States 63110
19 GSK Investigational Site Albuquerque New Mexico United States 87109
20 GSK Investigational Site Raleigh North Carolina United States 27609
21 GSK Investigational Site Akron Ohio United States 44304
22 GSK Investigational Site Cincinnati Ohio United States 45236
23 GSK Investigational Site Cleveland Ohio United States 44106
24 GSK Investigational Site Toledo Ohio United States 43614-5809
25 GSK Investigational Site Fort Worth Texas United States 76104
26 GSK Investigational Site San Antonio Texas United States 78229
27 GSK Investigational Site Green Bay Wisconsin United States 54301
28 GSK Investigational Site La Crosse Wisconsin United States 54601
29 GSK Investigational Site Madison Wisconsin United States 53792
30 GSK Investigational Site Milwaukee Wisconsin United States 53215
31 GSK Investigational Site Wausau Wisconsin United States 54401

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, MD, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043862
Other Study ID Numbers:
  • 104864/535
First Posted:
Aug 15, 2002
Last Update Posted:
May 31, 2017
Last Verified:
Mar 1, 2013
Keywords provided by GlaxoSmithKline
Hycamtin
oral
Radiation Sensitization
Small Cell Lung Cancer
newly diagnosed
limited stage
topotecan
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan

Study Results

No Results Posted as of May 31, 2017