The purpose of this study is to find out if the treatment combination of paclitaxel and lovastatin is more effective than the currently available chemotherapy for refractory or relapsed ovarian cancer. This research is being done to improve on currently available chemotherapy for ovarian cancer.
The main goal of the study is to find out if adding lovastatin to paclitaxel increases the number of people whose tumors shrink or whose disease responds to the treatment. Another purpose of the study is to find out how long tumors stay reduced in size before growing again as well as how long people live after receiving paclitaxel and lovastatin. The study will also gather information on the side effects, if any, of this combination of paclitaxel and lovastatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin, 80 mg, po, daily will be self-administered by the subject.
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination * Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.) * Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment.
Time frame: 8 weeks
Time to Progression Using the Combination of Lovastatin and Paclitaxel.
To determine the time to progression using the combination of lovastatin and paclitaxel.
Time frame: Up to one year
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