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Study Summary
No. 2006-0764:.......Advanced Cancers; Lymphoma; Myeloma; Solid Tumors......Gerald Falchook......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2006-0764
Study Title:A Phase I Trial of Bevacizumab and Bortezomib in Patients with Advanced Malignancy
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Physician New Patient Referral
Name:Gerald FalchookPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1930
Contact us about clinical trials
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General Information
Disease Group:Advanced Cancers
Lymphoma
Myeloma
Solid Tumors
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Days 1, 4, 8, and 11 every 21-days
Treatment
Agents:
Bevacizumab
Bortezomib
Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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.
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Study Objectives / Outcomes
1.1 Primary objective:

1.1.1 To determine the maximum tolerated dose (MTD) and dose-limiting
toxicities (DLT) of combination treatment with bevacizumab and
bortezomib.

1.2 Secondary objectives:

1.2.1 Preliminary descriptive assessment of anti-tumor efficacy.

1.2.2 Assessment of anti-angiogenesis correlates.
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Study Status Information
Study Activation / Registration Date:01/25/2007
IRB Review and Approval Date:11/01/2006
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:111
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.

2) 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.

3) ECOG performance status </= 2 (Karnofsky >/= 60%).

4) 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 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN.

5) 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.

6) Ability to understand and the willingness to sign a written informed consent document.

7) Life expectancy of at least 3 months.

Exclusion Criteria:1) Patients with hemoptysis within 28 days prior to entering the study.

2) Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.

3) Uncontrolled systemic vascular hypertension.

4) Patients with clinically significant cardiovascular disease, including: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, unstable angina pectoris.

5) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.

6) Pregnant or lactating women.

7) History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.

8) History of hypersensitivity to bortezomib, boron, mannitol, or any component of the formulation.

9) (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.

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Links
Registration Number: NCT00428545
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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