Clinical trial · Interventional
Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
A Phase I Trial of Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
NCT00610493CI-TRIAL-00030725completedPhase 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 Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.
Conditions
Conditions (1)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional Blood Drawn | Procedure | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Biopsy | Procedure | — | UNRESOLVED |
| DCE-MRI Scan | Procedure | — | UNRESOLVED |
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + Temsirolimus
- description
- Bevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1.
- interventionNames
- Drug: Bevacizumab
- Drug: Temsirolimus
- Procedure: Additional Blood Drawn
- Procedure: Biopsy
- Procedure: DCE-MRI Scan
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 21 days
- description
- Maximum tolerated dose defined as the dose level below the dose at which two of six patients experience drug-related dose limiting toxicity in the first cycle.
Secondary outcomes (1)
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 CR rate of at least 10% or improves survival by at least three months. 2. Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available. 3. ECOG performance status \</= 2 (Karnofsky \>/= 60%). 4. Patients must have allowable organ and marrow function defined as: absolute neutrophil count \>/= 1,000/mL; platelets \>/=50,000/mL; creatinine \</= 3 X ULN; total bilirubin \</= 3.0; AST(SGOT)/ALT(SGPT) \</= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL. 5. 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. 6. Ability to understand and the willingness to sign a written informed consent document 7. Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies. 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 (Systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg on medication). 4. Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris 5. Pregnant or lactating women. 6. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation. 7. History of hypersensitivity to Temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation 8. Patients that are taking CYP3A4 inducers and/or inhibitors. Please see section 3.2 in the protocol for details. If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.