- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585052
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
December 5, 2017 updated by: Raymond J Hohl, University of Iowa
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52327
- Holden Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Other Names:
Lovastatin, 80 mg, po, daily will be self-administered by the subject.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression Using the Combination of Lovastatin and Paclitaxel.
Time Frame: Up to one year
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To determine the time to progression using the combination of lovastatin and paclitaxel.
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Up to one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raymond Hohl, MD, University of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Actual)
January 5, 2018
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Paclitaxel
- Lovastatin
- L 647318
- Dihydromevinolin
Other Study ID Numbers
- 200305074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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