Advanced CancerPhase 1NCT01054313
Docetaxel and Sirolimus in Patients With Advanced Malignancies
A Phase 1 study testing Docetaxel (Taxotere), Sirolimus (Rapamycin) and Prednisone in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Docetaxel (Taxotere), Sirolimus (Rapamycin) and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must be at least 5 half-lives or three weeks, whichever is shorter, from their previous targeted or biologic therapy; patients must be at least three weeks beyond previous cytotoxic therapy. In addition, patients must be >/= 3 weeks beyond previous therapeutic radiation or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered only to the site of disease being treated under this protocol. Terminal phase half life of docetaxel is 11.1 hours; sirolimus, 14.5 hours.
- cont'd from criterion #2 Previous mTOR inhibitor (everolimus, temsirolimus, and sirolimus) and taxane (including paclitaxel, abraxane/ABI-007, and docetaxel) therapy is permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 3
- Patients must have normal organ and marrow function defined as:absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 2 x upper limit of normal (ULN); total bilirubin </= 3x ULN; ALT(SGPT) </= 3 x ULN; cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
- Patients must be able to understand and be willing to sign a written informed consent document.
- Patients already on gonadotropin-releasing hormone (GnRH) agonist therapy (eg goserelin acetate, leuprolide acetate) for metastatic, castrate-resistant prostate cancer for three months prior to entry into this study may be continued on this intervention while enrolled in this protocol. Patients on somatostatin analogues (eg octreotide) for symptom control for three months prior to entry into this study may be continued on this intervention while enrolled in this protocol.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, and need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to docetaxel or any component of the formulation.
- History of hypersensitivity to sirolimus or any component of the formulation
- Patients maintained on medications that are strong inducers or inhibitors of CYP3A4 should have these medications discontinued prior to entry on study unless cessation of such medications would be detrimental to patient's health.
- Patients unwilling or unable to sign informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies
The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer.
Researchers also want to find highest tolerated dose of the combination of docetaxel, sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of both drug combinations will also be studied.
Read the detailed description
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in tumor tissue as well.
Sirolimus is designed to block a protein called mammalian target of rapamycin (mTOR) inside the cancer cell.
Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with chemotherapy to treat cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of docetaxel and sirolimus based on when you joined this study. Up to 12 dose levels of docetaxel and sirolimus will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of docetaxel and sirolimus is found. Once the highest tolerable dose of docetaxel and sirolimus is found, up to 12 more patients may be enrolled to further study the safety of the drug at each of that dose.
If you have prostate cancer, you will also receive prednisone. All participants who receive prednisone will receive the same dose level.
Study Drug Administration:
Each study cycle is 21 days.
Everyday, you will take sirolimus by mouth 1 time a day. Sirolimus can be taken with or without food, but should be taken at the same time everyday.
On Day 1 of every cycle, you will receive docetaxel by vein over about 1 hour.
If you are taking prednisone, you will take it 2 times every day by mouth with food and water.
Study Visits:
Every week for the first 3 weeks and then about every 3 weeks, blood (about 5 teaspoons) will be drawn for routine tests. You will also have a physical exam.
Every 6 weeks, women who are able to have children will have blood drawn for a pregnancy test.
About every three weeks, blood (about 5 teaspoons) will be drawn for routine tests, to check your kidney function, and for biomarker tests.
About every 6 weeks, you will have a CT scan and x-ray to check the status of the disease.
Length of Study:
You will be on study for as long as you are benefitting. You will be taken off the study if the disease gets worse or you experience intolerable side effects.
Follow-Up:
If you experience intolerable side effects, you will be followed until the side effect has resolved or the side effect does not continue to improve or get worse. The study doctor will tell you what tests will need to be performed.
This is an investigational study. Docetaxel is FDA approved and commercially available for the treatment of advanced cancers such as breast, lung, and prostate cancer. Sirolimus is FDA approved and commercially available for the prevention of transplant rejection in kidney transplant patients. Prednisone is FDA approved and commercially available for the treatment of prostate cancer when given with docetaxel.
The combination of docetaxel and sirolimus, with or without prednisone, to treat advanced cancer is investigational. Most patients in this study will receive docetaxel and sirolimus. However, if you have prostate cancer, you will receive docetaxel, prednisone, and sirolimus.
Up to 68 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Docetaxel (Taxotere), Sirolimus (Rapamycin), Prednisone
- Keywords
- Advanced Malignancies, Taxotere, Docetaxel, Rapamycin, Sirolimus, Rapamune, Prednisone, Resistant to standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel (Taxotere)Drug
Starting dose 30 mg/m^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.
Sirolimus (Rapamycin)Drug
Also called Rapamune
Starting dose 1 mg daily by mouth 1 time a day.
PrednisoneDrug
5 mg by mouth twice a day with prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + Sirolimus | Experimental | Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily Receives: Drug: Docetaxel (Taxotere); Drug: Sirolimus (Rapamycin); Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus
Measured: Every week for first 3 weeks then every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Janku, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054313
- Sponsor's protocol ID
- 2009-0558
- Other IDs
- NCI-2011-00545
- Status last verified
- Oct 2015
- First submitted
- 20 Jan 2010
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01054313
- Acronym / sponsor ID
- 2009-0558
- Conditions
- Advanced Cancer
- Keywords
- Advanced Malignancies, Taxotere, Docetaxel, Rapamycin, Sirolimus, Rapamune, Prednisone, Resistant to standard therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer.
Researchers also want to find highest tolerated dose of the combination of docetaxel, sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of both drug combinations will also be studied.
Detailed description
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in tumor tissue as well.
Sirolimus is designed to block a protein called mammalian target of rapamycin (mTOR) inside the cancer cell.
Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with chemotherapy to treat cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of docetaxel and sirolimus based on when you joined this study. Up to 12 dose levels of docetaxel and sirolimus will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of docetaxel and sirolimus is found. Once the highest tolerable dose of docetaxel and sirolimus is found, up to 12 more patients may be enrolled to further study the safety of the drug at each of that dose.
If you have prostate cancer, you will also receive prednisone. All participants who receive prednisone will receive the same dose level.
Study Drug Administration:
Each study cycle is 21 days.
Everyday, you will take sirolimus by mouth 1 time a day. Sirolimus can be taken with or without food, but should be taken at the same time everyday.
On Day 1 of every cycle, you will receive docetaxel by vein over about 1 hour.
If you are taking prednisone, you will take it 2 times every day by mouth with food and water.
Study Visits:
Every week for the first 3 weeks and then about every 3 weeks, blood (about 5 teaspoons) will be drawn for routine tests. You will also have a physical exam.
Every 6 weeks, women who are able to have children will have blood drawn for a pregnancy test.
About every three weeks, blood (about 5 teaspoons) will be drawn for routine tests, to check your kidney function, and for biomarker tests.
About every 6 weeks, you will have a CT scan and x-ray to check the status of the disease.
Length of Study:
You will be on study for as long as you are benefitting. You will be taken off the study if the disease gets worse or you experience intolerable side effects.
Follow-Up:
If you experience intolerable side effects, you will be followed until the side effect has resolved or the side effect does not continue to improve or get worse. The study doctor will tell you what tests will need to be performed.
This is an investigational study. Docetaxel is FDA approved and commercially available for the treatment of advanced cancers such as breast, lung, and prostate cancer. Sirolimus is FDA approved and commercially available for the prevention of transplant rejection in kidney transplant patients. Prednisone is FDA approved and commercially available for the treatment of prostate cancer when given with docetaxel.
The combination of docetaxel and sirolimus, with or without prednisone, to treat advanced cancer is investigational. Most patients in this study will receive docetaxel and sirolimus. However, if you have prostate cancer, you will receive docetaxel, prednisone, and sirolimus.
Up to 68 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Sirolimus | Experimental | Drug: Docetaxel (Taxotere), Drug: Sirolimus (Rapamycin), Drug: PrednisoneStarting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must be at least 5 half-lives or three weeks, whichever is shorter, from their previous targeted or biologic therapy; patients must be at least three weeks beyond previous cytotoxic therapy. In addition, patients must be >/= 3 weeks beyond previous therapeutic radiation or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered only to the site of disease being treated under this protocol. Terminal phase half life of docetaxel is 11.1 hours; sirolimus, 14.5 hours.
- cont'd from criterion #2 Previous mTOR inhibitor (everolimus, temsirolimus, and sirolimus) and taxane (including paclitaxel, abraxane/ABI-007, and docetaxel) therapy is permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 3
- Patients must have normal organ and marrow function defined as:absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 2 x upper limit of normal (ULN); total bilirubin </= 3x ULN; ALT(SGPT) </= 3 x ULN; cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL.
Key exclusion criteria (6 listed)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, and need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to docetaxel or any component of the formulation.
- History of hypersensitivity to sirolimus or any component of the formulation
- Patients maintained on medications that are strong inducers or inhibitors of CYP3A4 should have these medications discontinued prior to entry on study unless cessation of such medications would be detrimental to patient's health.
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 |
|---|---|---|
| Docetaxel (Taxotere)Starting dose 30 mg/m^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle. | Drug | Docetaxel + Sirolimus |
| Sirolimus (Rapamycin)Also: RapamuneStarting dose 1 mg daily by mouth 1 time a day. | Drug | Docetaxel + Sirolimus |
| Prednisone5 mg by mouth twice a day with prostate cancer. | Drug | Docetaxel + Sirolimus |
Primary outcome
Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus
Time frame: Every week for first 3 weeks then every 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Filip Janku, MD, PHD principal investigator
M.D. Anderson Cancer Center
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 Docetaxel (Taxotere), Sirolimus (Rapamycin) and Prednisone in people with Advanced Cancer, run by M.D. Anderson Cancer Center 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 7 Oct 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus (time frame: Every week for first 3 weeks then every 3 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 7 Oct 2015.