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A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies

Phase 1
Open (Enrolling)
Advanced Cancer

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Trial Information

A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies

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 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

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

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.


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.

Inclusion Criteria:

1. 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.

2. 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.

3. cont'd from criterion #2 Previous mTOR inhibitor (everolimus, temsirolimus, and
sirolimus) and taxane (including paclitaxel, abraxane/ABI-007, and docetaxel) therapy
is permitted.

4. ECOG performance status
5. Patients must have normal organ and marrow function defined as:absolute neutrophil
count >/= 1,000/mL; platelets >/=50,000/mL; creatinine mg/dL.

6. 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.

7. Patients must be able to understand and be willing to sign a written informed consent

8. Patients already on 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.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, uncontrolled asthma, need for hemodialysis, and need for ventilatory

2. Pregnant or lactating women.

3. History of hypersensitivity to docetaxel or any component of the formulation.

4. History of hypersensitivity to sirolimus or any component of the formulation

5. 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.

6. Patients unwilling or unable to sign informed consent document.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus

Outcome Time Frame:

Every week for first 3 weeks then every 3 weeks

Safety Issue:


Principal Investigator

Filip Janku, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Advanced Malignancies
  • Taxotere
  • Docetaxel
  • Rapamycin
  • Sirolimus
  • Rapamune
  • Prednisone
  • Resistant to standard therapy
  • Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030