AzTrials
AzTrials

Lung Cancer, Non-Small CellPhase 2NCT00065182

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

A Phase 2 study testing Topotecan/Docetaxel combination and Docetaxel in people with Lung Cancer, Non-Small Cell and Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 85 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Topotecan/Docetaxel combination and Docetaxel
How many people
399 participants
Where
85 sitesin 3 countries
Study dates
14 Aug 2003to 30 Aug 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

85 sites in 3 countries.

85 sites in 3 countries

United States67 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24211

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70808

  • GSK Investigational Site

    Boca Raton, Florida, 33428

  • GSK Investigational Site

    Boca Raton, Florida, 33486

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Bowling Green, Kentucky, 42101

  • GSK Investigational Site

    Buffalo, New York, 14215-1199

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Casper, Wyoming, 85601

  • GSK Investigational Site

    Columbia, South Carolina, 29203

  • GSK Investigational Site

    Columbus, Georgia, 31902

  • GSK Investigational Site

    Decatur, Illinois, 62526

  • GSK Investigational Site

    Denver, Colorado, 80210

  • GSK Investigational Site

    Dunmore, Pennsylvania, 18512

  • GSK Investigational Site

    East Syracuse, New York, 13057

  • GSK Investigational Site

    Elk Grove Village, Illinois, 60007

  • GSK Investigational Site

    Fayetteville, North Carolina, 28302-2000

  • GSK Investigational Site

    Frederick, Maryland, 21701

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Grosse Pointe Woods, Michigan, 48236

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

  • GSK Investigational Site

    Hilton Head Island, South Carolina, 29926

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Irving, Texas, 75038

  • GSK Investigational Site

    Knoxville, Tennessee, 37916

  • GSK Investigational Site

    Lafayette, Louisiana, 70506

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lakeland, Florida, 33805

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Los Angeles, California, 90067

  • GSK Investigational Site

    Louisville, Kentucky, 40207

  • GSK Investigational Site

    Louisville, Kentucky, 40215

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Miami Shores, Florida, 33138

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53295

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407-3799

  • GSK Investigational Site

    Minneapolis, Minnesota, 55417

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Hyde Park, New York, 11040

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Nyack, New York, 10960

  • GSK Investigational Site

    Orange Park, Florida, 32073

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19114

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Reno, Nevada, 89502

  • GSK Investigational Site

    Robbinsdale, Minnesota, 55422

  • GSK Investigational Site

    Rochester, New York, 14623

  • GSK Investigational Site

    Sheboygan, Wisconsin, 53081

  • GSK Investigational Site

    Skokie, Illinois, 60077

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stuart, Florida, 34994

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tyler, Texas, 75701

  • GSK Investigational Site

    Urbana, Illinois, 61801

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20307-5001

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20422

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada13 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Kingston, Ontario, K7L 5P9

  • GSK Investigational Site

    Kitchener, Ontario, N2G 1G3

  • GSK Investigational Site

    Lévis, Quebec, G6V 3Z1

  • GSK Investigational Site

    London, Ontario, N6A 4L6

  • GSK Investigational Site

    Moncton, New Brunswick, E1C 8X3

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1C4

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    St. Catharines, Ontario, L2R 5K3

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Weston, Ontario, M9N 1N8

Other trials in Canada

Poland5 sites

  • GSK Investigational Site

    Kielce, 25-640

  • GSK Investigational Site

    Krakow, 31-115

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Szczecin Zdunowo 20, 70-891

Other trials in Poland

About this study

Official title: 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.

Being tested
Topotecan/Docetaxel combination, Docetaxel
Keywords
HYCAMTIN, TAXOTERE, non-small cell lung cancer, NSCLC, docetaxel, topotecan, Stage IIIB/IV, Advanced
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topotecan/Docetaxel combinationDrug

  • DocetaxelDrug

    Also called Topotecan/Docetaxel combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Time of Overall Survival

    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.

    Measured: Up to one year from Day -1 (randomization)

Secondary outcomes (10)

  1. Number of Participants With One-year Survival

    Number of participants with one-year survival were planned to be reported.

    Measured: Up to one year from Day -1 (randomization)

  2. Median Time to Progression

    Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.

    Measured: Up to one year from Day -1 (randomization)

  3. Response Rate

    Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.

    Measured: Up to one year from Day -1 (randomization)

  4. Response Duration

    Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.

    Measured: Up to one year from Day -1 (randomization)

  5. Time to Response-assessed Every 8 Weeks

    Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.

    Measured: Every 8 Weeks post randomization

  6. Assessment of Quality of Life-assessed Every 4 Weeks

    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).

    Measured: Every 4 Weeks post randomization

  7. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Up to 16 months

  8. Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities

    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.

    Measured: Up to 16 months

  9. Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities

    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.

    Measured: Up to 16 months

  10. Number of Participants With Clinically Significant Abnormal Vital Signs Data

    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.

    Measured: Up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2003 (estimated)
  2. Study start14 Aug 2003
  3. Primary completion30 Aug 2007
  4. Study completion30 Aug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065182
Sponsor's protocol ID
104864/615
Other IDs
2004-002892-17, 2004
Status last verified
Mar 2019
First submitted
17 Jul 2003
Last updated
24 Jun 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topotecan/Docetaxel combination and Docetaxel in people with Lung Cancer, Non-Small Cell and Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 85 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time of Overall Survival (time frame: Up to one year from Day -1 (randomization)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in