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Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

NCT00610493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2017-12-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bevacizumab

5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle

DRUG

Temsirolimus

5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle

PROCEDURE

Additional Blood Drawn

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.

PROCEDURE

Biopsy

First tumor biopsy during screening visit and Second at the end of Cycle 1

PROCEDURE

DCE-MRI Scan

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sarina Piha-Paul, MD · 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
2008-01-25
Primary Completion
2017-11-28
Completion
2017-11-28
FDA Drug
Yes

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 NCT00610493 on ClinicalTrials.gov