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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
Sponsor:
Information provided by (Responsible Party):
Raymond J Hohl, University of Iowa

December 21, 2007
January 2, 2008
October 10, 2017
January 5, 2018
January 5, 2018
August 2003
February 2010   (Final data collection date for primary outcome measure)
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.
Response rate of the combination of lovastatin and paclitaxel. [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00585052 on ClinicalTrials.gov Archive Site
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.
The duration of response and time to progression using the combination of lovastatin and paclitaxel. [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Paclitaxel
    Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
    Other Names:
    • Abraxane
    • Taxol
  • Drug: Lovastatin
    Lovastatin, 80 mg, po, daily will be self-administered by the subject.
    Other Names:
    • Mevacor
    • Altoprev
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.
Interventions:
  • Drug: Paclitaxel
  • Drug: Lovastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
30
June 2013
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with platinum refractory epithelial ovarian cancer: Defined as those patients with histologically confirmed epithelial ovarian cancer that have not responded (progressive or stable disease as a best response) to an initial chemotherapy regimen that included a platinum agent (cisplatin or carboplatin).
  • Patients with platinum resistant ovarian cancer: Defined as those patients with histologically confirmed epithelial ovarian cancer that have relapsed less than 6 months after completion of prior platinum based chemotherapy. If the patient had responded but progressed more than 6 months after completing therapy, the patient must have received at least one additional course of platinum containing chemotherapy or recurred within 6 months of discontinuation of the second-line treatment program.
  • Measurable Disease: 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. Lesions that are considered to be unmeasurable include the following: bone lesions, leptomeningeal disease, ascites and pleural/pericardial disease.
  • Prior treatment with any number of chemotherapeutic regimens is permitted as long as there was an interval of at least 4 weeks since the last chemotherapy.
  • Prior treatment with paclitaxel chemotherapy is permitted as long as it was administered on a >/= 3 week regimen and it has been at least 4 weeks since the last treatment.
  • Normal Hepatic function
  • Total Bilirubin < 2 times upper limits of normal range.
  • Transaminases < 2 times upper limits of normal range
  • Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women of reproductive potential should agree to use an effective means of birth control.

Exclusion Criteria:

  • Other serious illnesses, which would limit survival to <2 years, or a psychiatric condition, which would prevent compliance with treatment or informed consent.
  • Performance Status >2
  • Uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection, which in the opinion of the treating physician would make this protocol treatment unreasonably hazardous for the patient.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse within one year.
  • Patients who have received any investigational agent within the prior 4 weeks.
  • Age < 18 as there is no safety data for lovastatin in this age range.
Sexes Eligible for Study: Female
18 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00585052
200305074
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Raymond J Hohl, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Raymond Hohl, MD University of Iowa
University of Iowa
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP