NCT00065182CompletedPhase 2
WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 399
- Locations
- 85
- Primary Endpoint
- Median Time of Overall Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Number of Participants With One-year Survival(Up to one year from Day -1 (randomization))
- Median Time to Progression(Up to one year from Day -1 (randomization))
- Response Rate(Up to one year from Day -1 (randomization))
- Response Duration(Up to one year from Day -1 (randomization))
- Time to Response-assessed Every 8 Weeks(Every 8 Weeks post randomization)
- Assessment of Quality of Life-assessed Every 4 Weeks(Every 4 Weeks post randomization)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 16 months)
- Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities(Up to 16 months)
- Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities(Up to 16 months)
- Number of Participants With Clinically Significant Abnormal Vital Signs Data(Up to 16 months)
Investigators
Study Sites (85)
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