Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.
Trial record 2 of 10 for:    torisel AND bevacizumab AND M.D. anderson

Doxil, Bevacizumab and Temsirolimus Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761644
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Doxil Drug: Bevacizumab Drug: Temsirolimus Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Doxil, Bevacizumab and Temsirolimus
Actual Study Start Date : August 21, 2008
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Drug: Doxil
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
Other Names:
  • Liposomal doxorubicin
  • Doxorubicin hydrocholoride (liposomal)

Drug: Bevacizumab
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Temsirolimus
Days 1, 8 & 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
Other Names:
  • CCI-779
  • Torisel

Primary Outcome Measures :
  1. Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs) [ Time Frame: First cycle (21 days) ]
    MTD defined as dose level below dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in first cycle. Dose limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity defined in the NCI CTC v3.0, even if expected and believed related to the study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.

Secondary Outcome Measures :
  1. Anti-Tumor Efficacy of Drug Combination [ Time Frame: 4 months ]
    Anti-tumor efficacy assessed by RECIST criteria.

  2. Anti-Tumor Efficacy of Drug Combination [ Time Frame: 4 months ]
    Anti-tumor efficacy assessed by WHO criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
  5. Eastern Cooperative Oncology Group (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 upper limit of normal (ULN); total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 X ULN.
  7. Cardiac ejection fraction >/= 50% without evidence of congestive heart failure (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 Criteria:

  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 cerebral vascular accident (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
  9. Inability to swallow tablets for everolimus arm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761644

Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Layout table for investigator information
Principal Investigator: Daniel Karp, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00761644    
Other Study ID Numbers: 2008-0384
NCI-2012-01665 ( Registry Identifier: NCI CTRP )
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Anti-VEGF monoclonal antibody
Metastatic cancer
Liposomal doxorubicin
Doxorubicin hydrochloride (liposomal)
Dynamic contrast-enhanced magnetic resonance imaging
DCE-MRI scan
Additional relevant MeSH terms:
Layout table for MeSH terms
Liposomal doxorubicin
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents