Status:
COMPLETED
Bevacizumab and Bortezomib in Patients With Advanced Malignancy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Malignancy
Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of Avastin™ (bevacizumab) and Velcade™ (bortezomib) that can be given in combination to patients with a metastatic or unr...
Detailed Description
Bevacizumab is an anti-cancer drug designed to prevent or slow down the growth of cancer cells by blocking blood vessels that supply nutrients necessary for tumor growth. Bortezomib is an anti-cancer...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (CR) rate of at least 10% or improves survival by at least three months.
- Patients must be \>/= 6 weeks beyond treatment with nitrosoureas or mitomycin-C, \>/= 4 weeks beyond other chemo- or radiotherapy, and must have recovered to \</= grade 1 toxicity for any treatment-limiting toxicity of prior therapy. (Exception: patients who received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field). Patients who have received non-chemotherapeutic biologic agents must wait 5 half-lives or 4 weeks, whichever is shorter, from the last day of treatment.
- The Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 (Karnofsky \>/= 60%).
- Patients must have normal organ and marrow function defined as: leukocytes \>/= 3,000/mL; absolute neutrophil count \>/= 1,500/mL; platelets \>/=75,000/mL; creatinine \</= 2 \* Upper Limits of Normal (ULN); total bilirubin \</= 2.0; alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 \* ULN; ALT(SGPT) \</= 5 \* ULN.
- The effects of bevacizumab on the developing human fetus are unknown. Angiogenesis is of critical importance to fetal development, and bevacizumab is likely to have adverse consequences in terms of fetal development. For this reason, 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 30 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document.
- Life expectancy of at least 3 months.
Exclusion
- 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.
- Patients with clinically significant cardiovascular disease, including: history of cerebrovascular accident (CVA) within 6 months, myocardial infarction or unstable angina within 6 months, unstable angina pectoris.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to bortezomib, boron, mannitol, or any component of the formulation.
- (Only for the 10-patient expansion cohort after identification of the MTD): Patients must be willing to undergo biopsy before treatment and at the end of cycle 1.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00428545
Start Date
January 1 2007
End Date
November 1 2012
Last Update
February 12 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030