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Continuous Infusion Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer: Tumor Features and Phase II/Pharmacokinetic Evaluation
This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.
On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day will be administered via continuous infusion for 9 days beginning on Day 1 of every 21 day cycle. Additionally, patients will receive erlotinib 150 mg daily Days 1-9 in a cycle of 21 days. Thereafter both drugs will be given as long as patient benefit continues. Treatment will be administered on an inpatient or outpatient basis, repeating administration on an every 3 week cycle. A cycle will be one three-week course of the erlotinib-topotecan regimen (the cycle could be extended to 4 weeks if blood studies at 21 days result in treatment delay). The dose of topotecan will be calculated as follows: BSA (m\^2) X drug dose (mg/m\^2) = dose (mg)
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Bellevue Hospital Center
New York, New York, United States
NYU Clinical Cancer Center
New York, New York, United States
Tisch Hospital
New York, New York, United States
Start Date
August 1, 2009
Primary Completion Date
September 1, 2012
Completion Date
December 1, 2012
Last Updated
June 30, 2016
6
ACTUAL participants
Topotecan
DRUG
Erlotinib
DRUG
Lead Sponsor
NYU Langone Health
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
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