Bevacizumab and Bortezomib in Patients With Advanced Malignancy
A Phase I Trial of Bevacizumab and Bortezomib in Patients With Advanced Malignancy
1 other identifier
interventional
104
1 country
1
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 unresectable advanced malignancy. The safety and effectiveness of this drug combination will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2007
Longer than P75 for phase_1
1 active site
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
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 12, 2013
February 1, 2013
5.8 years
January 26, 2007
February 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) and Dose-limiting toxicities (DLT) of Combination Treatment with Bevacizumab and Bortezomib
The MTD is defined as the highest dose studied in which the incidence of DLT was less than 33%.
Weekly during 21 Day Cycle
Study Arms (1)
Bevacizumab + Bortezomib
EXPERIMENTALBevacizumab starting Dose 2.5 mg/kg By Vein On Day 1 Every 21 Days. Bortezomib starting Dose 0.7 mg/m\^2 By Vein On Days 1 and 8 Every 21 Days.
Interventions
Starting Dose 2.5 mg/kg By Vein On Day 1 Every 21 Days
Starting Dose 0.7 mg/m\^2 By Vein On Days 1 and 8 Every 21 Days
Eligibility Criteria
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 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.
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Falchook, MD
M.D. Anderson Cancer Center
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 26, 2007
First Posted
January 30, 2007
Study Start
January 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 12, 2013
Record last verified: 2013-02