Last updated: 07/18/2020 12:11:22
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Median time of overall survival
Timeframe: Up to one year from Day -1 (randomization)
Secondary outcomes:
Number of participants with one-year survival
Timeframe: Up to one year from Day -1 (randomization)
Median time to progression
Timeframe: Up to one year from Day -1 (randomization)
Response rate
Timeframe: Up to one year from Day -1 (randomization)
Response duration
Timeframe: Up to one year from Day -1 (randomization)
Time to response-assessed every 8 weeks
Timeframe: Every 8 Weeks post randomization
Assessment of Quality of life-assessed every 4 weeks
Timeframe: Every 4 Weeks post randomization
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 16 months
Number of participants with Grade 1, 2, 3 or 4 hematologic toxicities
Timeframe: Up to 16 months
Number of participants with Grade 3 or 4 clinical chemical toxicities
Timeframe: Up to 16 months
Number of participants with clinically significant abnormal vital signs data
Timeframe: Up to 16 months
Interventions:
Enrollment:
399
Primary completion date:
2007-30-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
August 2003 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Written informed consent
- At least 18 years old
- Concomitant malignancies or other malignancies within the last five years.
- Symptoms of brain metastases requiring treatment with steroids.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Terminated/Withdrawn
Showing 1 - 6 of 85 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-30-08
Actual study completion date
2007-30-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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