Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00610493
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle
  • Temsirolimus — DRUG
    5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle
  • Additional Blood Drawn — PROCEDURE
    2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.
  • Biopsy — PROCEDURE
    First tumor biopsy during screening visit and Second at the end of Cycle 1
  • DCE-MRI Scan — PROCEDURE
    DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1

Study Details

The goal of this clinical research study is to find the highest tolerable dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.

Key Dates

First listed
Feb 8, 2008
Start date
Jan 25, 2008
Status verified
Dec 2017
Primary completion
Nov 28, 2017
Completion
Nov 28, 2017

Study Design

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

Arms

  • Experimental: Bevacizumab + Temsirolimus
    Bevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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