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A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

Phase 1/Phase 2
19 Years
90 Years
Not Enrolling
Any Cancer, Breast Cancer

Thank you

Trial Information

A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

The primary objective of this study is to determine the maximum tolerated dose (MTD) of
lovastatin and docetaxel in patients with various different cancers (phase I). Once the MTD
for this drug combination has been determined, patients with breast cancer will be entered
into a single cohort, the phase II portion of this study, and treated with the MTD doses of
both lovastatin and docetaxel.

Inclusion Criteria:

- Age > 18 years of age

- Performance Status (ECOG) <2

- Peripheral Neuropathy < grade I

- Signed Informed consent

- Hematologic-Inclusion Absolute neutrophil count > 1,500/mm3 Hemoglobin > 8.0 g/dl
Platelet count > 100,000/mm3.

- Hepatic-Inclusion Total Bilirubin must be within normal limits.

- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of
normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to
4 x ULN if transaminases are < ULN.

- Patients may have received prior chemotherapy including treatment with the following
agents: anthracycline, platinum, vinorelbine, or other Vinca alkaloids. The patient
must have recovered from the side effects of the prior treatment including prior
drug-induced peripheral neuropathy.

- Patients who have received prior taxane therapy will be eligible. (However, patients
who have progressed within 6 months of receiving docetaxel will be excluded.)

- A minimum of 28 days must have elapsed from the completion of any prior chemotherapy
or radiation treatment.

- Patients who are currently receiving bisphosphonates for bone disease will be allowed
to enter the trial, however their bone lesions will not be considered assessable for
response, but will be assessable for progression.

- Initiation of bisphosphonate treatment during the trial will be discouraged but
allowed in the absence of progressive disease. If bisphosphonates are initiated,
then bone lesions will be assessed for progression only.

Exclusion Criteria:

- Other serious illnesses, which would limit survival to <2 months, or a psychiatric
condition, which would prevent compliance with treatment or informed consent.

- ECOG Performance Status >2

- Anticipated survival < 2 months

- 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.

- Patients with a history of severe hypersensitivity reaction to Taxotere® or other
drugs formulated with polysorbate 80.

- Patients who have received anticancer endocrine therapy within 4 weeks prior to
registration are not eligible.

- Patients currently on daily statin therapy will also be excluded.

- Patients who have progressed within 6 months of receiving docetaxel are not eligible.

- Treatment with the anti-emetic Aprepitant is not allowed.

- Patients who are currently receiving , or have received Herceptin therapy within 4
weeks prior to registration are not eligible.

- Pregnant and/or Nursing. Patients must not be pregnant or nursing at the time of
enrollment nor while under the treatment of this protocol. Treatment under this
protocol would expose an unborn child to significant risks. Women and men of
reproductive potential should agree to use an effective means of birth control.

Type of Study:


Study Design:

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

Outcome Measure:

For the Phase II portion of the study, the primary endpoint is frequency of objective response (complete response or partial response).

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Susan Roman, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

April 2009

Related Keywords:

  • Any Cancer
  • Breast Cancer
  • Any cancer
  • Breast cancer
  • Lovastatin
  • Docetaxel
  • Breast Neoplasms



Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009