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Doxil, Bevacizumab and Temsirolimus Trial
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761644
  Purpose

Primary objective:

To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of combination treatment with doxil, bevacizumab and temsirolimus.

Secondary objectives:

  • Preliminary descriptive assessment of anti-tumor efficacy.
  • Assessment of anti-angiogenesis and anti-HIF-1A correlates

Condition Intervention Phase
Advanced Cancer
Drug: Doxil
Drug: Bevacizumab
Drug: Temsirolimus
Procedure: CT or MRI Scan
Phase I

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Bevacizumab Immunoglobulins Globulin, Immune CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: A Phase I Trial of Doxil, Bevacizumab and Temsirolimus

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: August 2008
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Doxil, Bevacizumab and Temsirolimus
Drug: Doxil
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by IV over 3 hours
Drug: Bevacizumab
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by IV over 90 minutes
Drug: Temsirolimus
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by IV over 30 to 60 minutes
Procedure: CT or MRI Scan
Starting after Cycle 2, disease status checked by CT or MRI scan after every 2 cycles

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three months.
  2. All patients must have an estimated life expectancy of at least 12 weeks.
  3. Patients must have measurable or evaluable disease
  4. Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects.
  5. ECOG performance status </= 2 (Karnofsky >/= 60%).
  6. Patients must have organ and marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/=100,000/mL; creatinine </= 3 X ULN; total bilirubin </= 2.0; AST(SGOT)/ALT(SGPT) </= 5 X ULN.
  7. Cardiac ejection fraction >/= 50% without evidence of CHF
  8. 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.
  9. Ability to understand and the willingness to sign a written informed consent document.
  10. Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance treatment for prostate cancer.

Exclusion:

  1. Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
  2. Poorly controlled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
  3. Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris - New York Heart Association Class CHF score ≥ II
  4. Prior cumulative doxorubicin dose > 300 mg/m2
  5. Pregnant or lactating women
  6. History of hypersensitivity to doxil, doxorubicin, HCL, temsirolimus or it's metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
  7. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  8. Patients < 12 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761644

Contacts
Contact: Razelle Kurzrock, MD, BS 713-563-1930

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Razelle Kurzrock, MD, BS            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Razelle Kurzrock, MD, BS UT MD Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: UT MD Anderson Cancer Center ( Razelle Kurzrock MD, BS/Professor )
Study ID Numbers: 2008-0384
Study First Received: September 25, 2008
Last Updated: September 26, 2008
ClinicalTrials.gov Identifier: NCT00761644  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
metastatic cancer

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Neoplasm Metastasis
Bevacizumab
Doxorubicin
Immunoglobulins

Additional relevant MeSH terms:
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009