NCT00610493

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

9.8 years

First QC Date

January 25, 2008

Last Update Submit

December 6, 2017

Conditions

Advanced Cancer

Keywords

Advanced CancerBevacizumabTemsirolimusAvastinToriselCCI-779Anti-VEGF monoclonal antibodyrhuMAb-VEGFdynamic contrast-enhanced magnetic resonance imagingDCEmagnetic resonance imagingMRI

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Maximum tolerated dose defined as the dose level below the dose at which two of six patients experience drug-related dose limiting toxicity in the first cycle.

    21 days

Secondary Outcomes (1)

  • Anti-Tumor Efficacy

    Baseline, 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Cycles are 21 days.

Study Arms (1)

Bevacizumab + Temsirolimus

EXPERIMENTAL

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.

Drug: BevacizumabDrug: TemsirolimusProcedure: Additional Blood DrawnProcedure: BiopsyProcedure: DCE-MRI Scan

Interventions

BevacizumabDRUG

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

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Bevacizumab + Temsirolimus
TemsirolimusDRUG

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

Also known as: Torisel, CCI-779
Bevacizumab + Temsirolimus
Additional Blood DrawnPROCEDURE

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.

Bevacizumab + Temsirolimus
BiopsyPROCEDURE

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

Bevacizumab + Temsirolimus
DCE-MRI ScanPROCEDURE

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

Also known as: imaging scans, dynamic contrast-enhanced magnetic resonance imaging, DCE, magnetic resonance imaging, MRI
Bevacizumab + Temsirolimus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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 have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  • Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
  • ECOG performance status \</= 2 (Karnofsky \>/= 60%).
  • Patients must have allowable organ and marrow function defined as: absolute neutrophil count \>/= 1,000/mL; platelets \>/=50,000/mL; creatinine \</= 3 X ULN; total bilirubin \</= 3.0; AST(SGOT)/ALT(SGPT) \</= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/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 90 days after the last dose.
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.

You may not qualify if:

  • Patients with hemoptysis within 28 days prior to entering the study.
  • Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
  • Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg on medication).
  • Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris
  • Pregnant or lactating women.
  • History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  • History of hypersensitivity to Temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation
  • Patients that are taking CYP3A4 inducers and/or inhibitors. Please see section 3.2 in the protocol for details. If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

BevacizumabtemsirolimusBiopsyMagnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Sarina Piha-Paul, MD

    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 25, 2008

First Posted

February 8, 2008

Study Start

January 25, 2008

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations

US(1)