A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Paclitaxel; Lovastatin
Intervention description: 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.
Intervention MeSH terms: Paclitaxel; Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Epithelial Ovarian Cancer; Lovastatin; Paclitaxel

Summary:

      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.
    

Eligibility criteria:

        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.