Clinical trial · Interventional
Bevacizumab and Bortezomib in Patients With Advanced Malignancy
A Phase I Trial of Bevacizumab and Bortezomib in Patients With Advanced Malignancy
NCT00428545CI-TRIAL-00009434completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + Bortezomib
- description
- Bevacizumab 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.
- interventionNames
- Drug: Bevacizumab
- Drug: Bortezomib
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) and Dose-limiting toxicities (DLT) of Combination Treatment with Bevacizumab and Bortezomib
- timeFrame
- Weekly during 21 Day Cycle
- description
- The MTD is defined as the highest dose studied in which the incidence of DLT was less than 33%.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 complete response (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. The Eastern Cooperative Oncology Group (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 \* 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. 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 cerebrovascular accident (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.
References
Publications (0)
Data not yet available
No reference posted for this study.