RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer (NCT00253318) | Clinical Trial Compass
TerminatedPhase 1
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Stopped: Toxicity and Lack of Efficacy
United States15 participantsStarted 2005-11-01
Plain-language summary
Primary:
* To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I).
* To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I).
Secondary:
* To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
* To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older.
. Diagnosis of metastatic breast cancer with at least one measurable or evaluable lesion. For the phase II portion of the study patients will be required to have measurable disease. Response will be determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
. No limit on the prior number of chemotherapies for the phase I portion of the study. No more than one prior chemotherapy regimen for the phase II portion of the study.
. Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and potential risks by the investigator with the aid of written information.
. Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) \> or = 1.5 times 10(9)/L, Platelets \> or = 100 times 10(9)/L, Hgb \> or = 10g/dL.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether the RAD001 plus docetaxel combination is still considered a viable option for my situation?
2Since this was a Phase 1 trial focused on finding the maximum tolerated dose rather than proving the treatment works, what does that mean for how much we actually know about whether this combination is safe or effective for metastatic breast cancer?
3Given that this trial is no longer recruiting, are there other ongoing studies combining RAD001 (everolimus) with chemotherapy for metastatic breast cancer that might be worth looking into instead?
4How does this combination of RAD001 and docetaxel compare to the standard treatments currently available for my type of metastatic breast cancer — would it make sense to try established options first?
5Are there any published results from this trial, even though it was terminated, that might tell us something about the safety signals or dose-related side effects of combining these two drugs?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of combination of RAD001 plus Docetaxel
. Normal renal function as shown by serum creatinine \< or = 1.5 times Upper Limit of Normal (ULN).
. Hepatic Function Variables:
. Performance Status 0-2 on the World Health Organization (WHO) scale.
Exclusion criteria
. Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis \< 6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation.
. Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis.
. For the phase I portion of the study, patients with grade \> 2 neuropathy, for the phase II portion of the trial, patients with \> or = grade 2 neuropathy.
. For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation. However, patients with brain metastasis will be excluded from the phase II portion of the trial.
. Patients with an uncontrolled infection.
. Patients with a known history of HIV seropositivity.
. Patients with an active, bleeding diathesis, or on oral anti-vitamin K medication (except patients receiving 1 mg of warfarin to prevent central venous catheter thrombosis).
. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).