Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

March 29, 2019 updated by: GlaxoSmithKline

WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
399

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • GSK Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • GSK Investigational Site
      • London, Ontario, Canada, N6A 4L6
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K1H 1C4
        • GSK Investigational Site
      • St. Catharines, Ontario, Canada, L2R 5K3
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • GSK Investigational Site
      • Weston, Ontario, Canada, M9N 1N8
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Levis, Quebec, Canada, G6V 3Z1
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
  • Poland
      • Kielce, Poland, 25-640
        • GSK Investigational Site
      • Krakow, Poland, 31-115
        • GSK Investigational Site
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
      • Poznan, Poland, 60-569
        • GSK Investigational Site
      • Szczecin Zdunowo 20, Poland, 70-891
        • GSK Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Los Angeles, California, United States, 90067
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5001
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20422
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
      • Boca Raton, Florida, United States, 33428
        • GSK Investigational Site
      • Lakeland, Florida, United States, 33805
        • GSK Investigational Site
      • Miami Shores, Florida, United States, 33138
        • GSK Investigational Site
      • Orange Park, Florida, United States, 32073
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Stuart, Florida, United States, 34994
        • GSK Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31902
        • GSK Investigational Site
    • Illinois
      • Decatur, Illinois, United States, 62526
        • GSK Investigational Site
      • Elk Grove Village, Illinois, United States, 60007
        • GSK Investigational Site
      • Skokie, Illinois, United States, 60077
        • GSK Investigational Site
      • Urbana, Illinois, United States, 61801
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40215
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40207
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
      • Lafayette, Louisiana, United States, 70506
        • GSK Investigational Site
      • Lake Charles, Louisiana, United States, 70601
        • GSK Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21701
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55407-3799
        • GSK Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • Springfield, Missouri, United States, 65807
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • GSK Investigational Site
      • Reno, Nevada, United States, 89502
        • GSK Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • GSK Investigational Site
      • Buffalo, New York, United States, 14215-1199
        • GSK Investigational Site
      • East Syracuse, New York, United States, 13057
        • GSK Investigational Site
      • Manhasset, New York, United States, 11030
        • GSK Investigational Site
      • New Hyde Park, New York, United States, 11040
        • GSK Investigational Site
      • Nyack, New York, United States, 10960
        • GSK Investigational Site
      • Rochester, New York, United States, 14623
        • GSK Investigational Site
    • North Carolina
      • Fayetteville, North Carolina, United States, 28302-2000
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • GSK Investigational Site
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • GSK Investigational Site
      • Hilton Head Island, South Carolina, United States, 29926
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Irving, Texas, United States, 75038
        • GSK Investigational Site
      • Tyler, Texas, United States, 75701
        • GSK Investigational Site
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23507
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • GSK Investigational Site
      • Sheboygan, Wisconsin, United States, 53081
        • GSK Investigational Site
    • Wyoming
      • Casper, Wyoming, United States, 85601
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Written informed consent
  • At least 18 years old
  • Confirmed advanced non-small cell lung carcinoma (NSCLC)
  • Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
  • Presence of either measurable or non-measurable disease by radiologic study or physical examination.
  • Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
  • At least 7 days since prior radiotherapy.
  • A probable life expectance of at least 3 months.
  • Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

  • Concomitant malignancies or other malignancies within the last five years.
  • Symptoms of brain metastases requiring treatment with steroids.
  • Active infection.
  • Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
  • Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
  • Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
  • Women who are pregnant or lactating.
  • Subjects of child-bearing potential refusing to practice adequate contraception.
  • Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
  • Subjects who cannot receive steroid premedication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median Time of Overall Survival
Time Frame: Up to one year from Day -1 (randomization)
Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
Up to one year from Day -1 (randomization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With One-year Survival
Time Frame: Up to one year from Day -1 (randomization)
Number of participants with one-year survival were planned to be reported.
Up to one year from Day -1 (randomization)
Median Time to Progression
Time Frame: Up to one year from Day -1 (randomization)
Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.
Up to one year from Day -1 (randomization)
Response Rate
Time Frame: Up to one year from Day -1 (randomization)
Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.
Up to one year from Day -1 (randomization)
Response Duration
Time Frame: Up to one year from Day -1 (randomization)
Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.
Up to one year from Day -1 (randomization)
Time to Response-assessed Every 8 Weeks
Time Frame: Every 8 Weeks post randomization
Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.
Every 8 Weeks post randomization
Assessment of Quality of Life-assessed Every 4 Weeks
Time Frame: Every 4 Weeks post randomization
The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).
Every 4 Weeks post randomization
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 16 months
AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.
Up to 16 months
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Time Frame: Up to 16 months
Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.
Up to 16 months
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Time Frame: Up to 16 months
Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.
Up to 16 months
Number of Participants With Clinically Significant Abnormal Vital Signs Data
Time Frame: Up to 16 months
Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.
Up to 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2003

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 104864/615
  • 2004-002892-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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