A Phase 2 interventional study of Topotecan in Small Cell Lung Cancer and Carcinoma, Small Cell, sponsored by SCRI Development Innovations, LLC. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-10.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
All patients will receive weekly topotecan.
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Topotecan
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
Also known as: Hycamtin
Overall response rate
Time frame: 18 months
overall toxicity
Time frame: 18 months
time to progression
Time frame: 18 months
duration of response
Time frame: 18 months
overall survival
Time frame: 18 months
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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SCRI Development Innovations, LLC