Back to resultsA Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Lovastatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Epithelial Ovarian Cancer, Lovastatin, Paclitaxel
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.
Sites / Locations
- Holden Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel and lovastatin
Arm Description
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Outcomes
Primary Outcome Measures
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
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.
Secondary Outcome Measures
Time to Progression Using the Combination of Lovastatin and Paclitaxel.
To determine the time to progression using the combination of lovastatin and paclitaxel.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00585052
Brief Title
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Official Title
A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual, PI left the institution
Study Start Date
August 2003 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, Epithelial Ovarian Cancer, Lovastatin, Paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel and lovastatin
Arm Type
Experimental
Arm Description
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Abraxane, Taxol
Intervention Description
Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Intervention Type
Drug
Intervention Name(s)
Lovastatin
Other Intervention Name(s)
Mevacor, Altoprev
Intervention Description
Lovastatin, 80 mg, po, daily will be self-administered by the subject.
Primary Outcome Measure Information:
Title
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Description
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 Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to Progression Using the Combination of Lovastatin and Paclitaxel.
Description
To determine the time to progression using the combination of lovastatin and paclitaxel.
Time Frame
Up to one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Hohl, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52327
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
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