Doxil, Bevacizumab and Temsirolimus Trial

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT00761644

Run by

M.D. Anderson Cancer Center

People needed

200

Starts

2008-08-21

Expected to finish

2019-03-28

Last updated by the study team

2019-04-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• All patients must have an estimated life expectancy of at least 12 weeks.
• Patients must have measurable or evaluable disease
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
• 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.
• Cardiac ejection fraction >/= 50% without evidence of congestive heart failure (CHF).
• 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 except hormonal maintenance treatment for prostate cancer.

You may not qualify if…

• Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
• Poorly controlled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
• 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
• Prior cumulative doxorubicin dose > 300 mg/m2
• Pregnant or lactating women
• History of hypersensitivity to doxil, doxorubicin, HCL, temsirolimus or it's metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Patients < 12 years of age
• Inability to swallow tablets for everolimus arm.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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