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
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Paclitaxel
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.
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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 |
Responsible Party: | Raymond J Hohl, Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT00585052 History of Changes |
Other Study ID Numbers: |
200305074 |
First Posted: | January 2, 2008 Key Record Dates |
Results First Posted: | January 5, 2018 |
Last Update Posted: | January 5, 2018 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Keywords provided by Raymond J Hohl, University of Iowa:
Ovarian Cancer Epithelial Ovarian Cancer Lovastatin Paclitaxel |
Additional relevant MeSH terms:
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Paclitaxel Albumin-Bound Paclitaxel Lovastatin |
L 647318 Dihydromevinolin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |