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A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of the combination of lovastatin and paclitaxel.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Raymond Hohl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Food and Drug Administration

Study ID:

200305074

NCT ID:

NCT00585052

Start Date:

August 2003

Completion Date:

December 2011

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Lovastatin
  • Paclitaxel
  • Ovarian Neoplasms

Name

Location

Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009