Any CancerPhase 1NCT00584012
A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer
A Phase 1 study testing Lovastatin and Docetaxel in people with Any Cancer and Breast Cancer, run by Susan L Roeder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Any Cancer, Breast Cancer
- What is being tested?
- Lovastatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Any Cancer, Breast Cancer
- Being tested
- Lovastatin, Docetaxel
- Keywords
- Any cancer, Breast cancer, Lovastatin, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovastatinDrug
Also called Mevacor
Given PO
DocetaxelDrug
Also called Taxotere
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lovastatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startApr 2004
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Any CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan L Roeder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susan L Roeder, University of Iowa
- Investigators
- Susan Roman, DO, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584012
- Sponsor's protocol ID
- 200311038
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2007
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer
- ClinicalTrials.gov ID
- NCT00584012
- Acronym / sponsor ID
- 200311038
- Conditions
- Any Cancer, Breast Cancer
- Keywords
- Any cancer, Breast cancer, Lovastatin, Docetaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Susan L RoederUniversity, hospital or other
- Study start
- Apr 2004 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Esclation | Experimental | Drug: Lovastatin, Drug: DocetaxelDetermine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LovastatinAlso: MevacorGiven PO | Drug | Dose Esclation |
| DocetaxelAlso: TaxotereGiven IV | Drug | Dose Esclation |
Primary outcome
Incidence of Dose-limiting Toxicities (DLTs)
Time frame: 27 weeks
To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Roman, DO principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lovastatin and Docetaxel in people with Any Cancer and Breast Cancer, run by Susan L Roeder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting Toxicities (DLTs) (time frame: 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.