Expired Study
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Iowa City, Iowa 52242


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

200311038


NCT ID:

NCT00584012


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Iowa


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:

Funding issues


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

96


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Susan Roman, DO
Principal Investigator
University of Iowa

Study Dates

Start Date:April 2004
Completion Date:April 2009
Completion Type:Anticipated
Primary Completion Date:April 2009
Primary Completion Type:Anticipated
Verification Date:June 2009
Last Changed Date:June 18, 2009
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lovastatin and Docetaxel
Description: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
Other Name:Mevacor

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Iowa

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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