Doxil, Bevacizumab and Temsirolimus Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00761644
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxil — DRUG
    Day 1 of each 21 day cycle, beginning dose level 10 mg/m\^2 by vein over 3 hours.
  • Bevacizumab — DRUG
    Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
  • Temsirolimus — DRUG
    Days 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.

Study Details

The goal of this clinical research study is to learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. The safety and effectiveness of this combination of drugs will also be studied.

Key Dates

First listed
Sep 29, 2008
Start date
Aug 21, 2008
Status verified
Apr 2019
Primary completion
Mar 28, 2019
Completion
Mar 28, 2019

Study Design

Enrollment
200 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Doxil, Bevacizumab + Temsirolimus
    Doxil day 1 of each 21 day cycle, beginning dose level 10 mg/m\^2 by vein over 3 hours. Bevacizumab day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes. Temsirolimus days 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.

Primary Outcome Measure

Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs) [ Time Frame: First cycle (21 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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