Any Cancer, Breast Cancer
Conditions
Keywords
Any cancer, Breast cancer, Lovastatin, Docetaxel
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.
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.
Interventions
DRUGLovastatin
Given PO
DRUGDocetaxel
Given IV
Sponsors
Susan L Roeder
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-limiting Toxicities (DLTs) | 27 weeks | To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Esclation Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks 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 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Dose Esclation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 56.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
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.
Time frame: 27 weeks
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.