A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00585052|
Recruitment Status : Terminated (Slow accrual, PI left the institution)
First Posted : January 2, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Paclitaxel Drug: Lovastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||June 2013|
U.S. FDA Resources
Experimental: Paclitaxel and lovastatin
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Other Names:Drug: Lovastatin
Lovastatin, 80 mg, po, daily will be self-administered by the subject.
- Tumor Response Rate of the Combination of Lovastatin and Paclitaxel. [ Time Frame: 8 weeks ]
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 to Progression Using the Combination of Lovastatin and Paclitaxel. [ Time Frame: Up to one year ]To determine the time to progression using the combination of lovastatin and paclitaxel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585052
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52327|
|Principal Investigator:||Raymond Hohl, MD||University of Iowa|