Docetaxel and Sirolimus in Patients With Advanced Malignancies

NCT01054313 | Completed Phase 1

• 2 other identifiers: 2009-0558NCI-2011-00545
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Advanced Malignancies; Taxotere; Docetaxel; Rapamycin; Sirolimus; Rapamune; Prednisone; Resistant to standard therapy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus

  Every week for first 3 weeks then every 3 weeks

Study Arms (1)

Docetaxel + Sirolimus

EXPERIMENTAL

Starting doses of Docetaxel 30 mg/m\^2 IV every 3 weeks + Sirolimus 1 mg daily

Drug: Docetaxel (Taxotere); Drug: Sirolimus (Rapamycin); Drug: Prednisone

Interventions

Docetaxel (Taxotere) DRUG

Starting dose 30 mg/m\^2 by vein (IV) over about 1 hour on Day 1 of every 21 day cycle.

Docetaxel + Sirolimus

Sirolimus (Rapamycin) DRUG

Starting dose 1 mg daily by mouth 1 time a day.

Also known as: Rapamune

Docetaxel + Sirolimus

Prednisone DRUG

5 mg by mouth twice a day with prostate cancer.

Docetaxel + Sirolimus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Docetaxel; Sirolimus; Prednisone

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Macrolides; Lactones; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Filip Janku, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)