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

This study has been terminated.
(Funding issues)
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00584012
First received: December 21, 2007
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin. There are two phases. Subjects in Phase I can have any cancer. This phase will determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Phase II will administer lovastatin and docetaxel only to subjects who have breast cancer tumors.


Condition Intervention Phase
Any Cancer
Breast Cancer
Drug: Lovastatin and Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • For the Phase II portion of the study, the primary endpoint is frequency of objective response (complete response or partial response). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: April 2004
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lovastatin and Docetaxel
    Docetaxel (60 mg/m2) will be given on day 0 every three weeks in Phase I with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this phase I/II study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
    Other Names:
    • Mevacor
    • Taxotere
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584012

Locations
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Susan Roman, DO University of Iowa
  More Information

No publications provided

Responsible Party: Susan Roman, DO, University of Iowa
ClinicalTrials.gov Identifier: NCT00584012     History of Changes
Other Study ID Numbers: 200311038
Study First Received: December 21, 2007
Last Updated: June 18, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Iowa:
Any cancer
Breast cancer
Lovastatin
Docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Lovastatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014