Docetaxel and Sirolimus in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054313
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Docetaxel (Taxotere) Drug: Sirolimus (Rapamycin) Drug: Prednisone Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies
Study Start Date : January 2010
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Docetaxel + Sirolimus
Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily
Drug: Docetaxel (Taxotere)
Starting dose 30 mg/m^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.
Drug: Sirolimus (Rapamycin)
Starting dose 1 mg daily by mouth 1 time a day.
Other Name: Rapamune
Drug: Prednisone
5 mg by mouth twice a day with prostate cancer.

Primary Outcome Measures :
  1. Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus [ Time Frame: Every week for first 3 weeks then every 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Eastern Cooperative Oncology Group (ECOG) performance status </= 3
  5. 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.
  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 document.
  8. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054313

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Filip Janku, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01054313     History of Changes
Other Study ID Numbers: 2009-0558
NCI-2011-00545 ( Registry Identifier: NCI CTRP )
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies
Resistant to standard therapy

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors