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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Paclitaxel
Drug: Lovastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly

Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.


Participant Flow:   Overall Study
    Paclitaxel and Lovastatin
STARTED   11 
COMPLETED   10 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly

Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.


Baseline Measures
   Paclitaxel and Lovastatin 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  81.8% 
>=65 years      2  18.2% 
Age 
[Units: Years]
Mean (Full Range)
 61.6 
 (51 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      11 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   11 


  Outcome Measures

1.  Primary:   Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.   [ Time Frame: 8 weeks ]

2.  Secondary:   Time to Progression Using the Combination of Lovastatin and Paclitaxel.   [ Time Frame: Up to one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trial closed early due to slow accrual, PI left the institution


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Raymond Hohl, MD
Organization: University of Iowa
phone: 319-335-6564
e-mail: rhohl@pennstatehealth.psu.edu



Responsible Party: Raymond J Hohl, University of Iowa
ClinicalTrials.gov Identifier: NCT00585052     History of Changes
Other Study ID Numbers: 200305074
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: October 10, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018