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Docetaxel and Sirolimus in Patients With Advanced Malignancies

NCT01054313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-10-07

No results posted yet for this study

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

Interventions

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.

DRUG

Prednisone

5 mg by mouth twice a day with prostate cancer.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Filip Janku, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054313 on ClinicalTrials.gov