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

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ClinicalTrials.gov Identifier: NCT00065182
Recruitment Status : Completed
First Posted : July 18, 2003
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer Drug: Topotecan/Docetaxel combination Drug: Docetaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
Actual Study Start Date : August 14, 2003
Actual Primary Completion Date : August 30, 2007
Actual Study Completion Date : August 30, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Intervention Details:
  • Drug: Topotecan/Docetaxel combination
  • Drug: Docetaxel
    Other Name: Topotecan/Docetaxel combination

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065182


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00065182    
Other Study ID Numbers: 104864/615
2004-002892-17 ( EudraCT Number )
First Posted: July 18, 2003    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019
Last Verified: March 2019
Keywords provided by GlaxoSmithKline:
HYCAMTIN
TAXOTERE
non-small cell lung cancer
NSCLC
 docetaxel
topotecan
Stage IIIB/IV
Advanced
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Docetaxel
Topotecan
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors