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

NCT00584012 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 200311038
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to 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. Subjects can have any cancer.

Conditions

Any Cancer; Breast Cancer

Keywords

Any cancer; Breast cancer; Lovastatin; Docetaxel

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-limiting Toxicities (DLTs)

  To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.

  27 weeks

Study Arms (1)

Dose Esclation

EXPERIMENTAL

Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.

Drug: Lovastatin; Drug: Docetaxel

Interventions

Lovastatin DRUG

Given PO

Also known as: Mevacor

Dose Esclation

Docetaxel DRUG

Given IV

Also known as: Taxotere

Dose Esclation

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of age
• Performance Status (ECOG) \<2
• Peripheral Neuropathy \< grade I
• Signed Informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Susan L Roeder: lead

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lovastatin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Limitations and Caveats

Study terminated due to funding issues prior to completion. No data were analyzed. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.

Results Point of Contact

• Title: Cena Jones-Bitterman
• Organization: Holden Comprehensive Cancer Center

cena-jones@uiowa.edu

319-353-4596

Study Officials

• Susan Roman, DO

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: April 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)