Clinical trial · Interventional
Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
NCT00601926CI-TRIAL-00018264terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor patient accrual. Attempts to open at other sites unsuccessful.
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- 15 mg/kg over 90 minutes
- interventionNames
- Biological: bevacizumab
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
- timeFrame
- Up to 2 years
- description
- Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- measure
- Response Rate to Bevacizumab in This Population.
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed papillary renal cell carcinoma (RCC) * Unresectable and/or metastatic disease * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 10 mm by spiral CT scan * No known CNS (central nervous system) disease PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * Life expectancy \> 6 months * ANC (absolute neutrophil count) ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Total bilirubin ≤ 2.0 mg/dL * AST (aspartate aminotransferase) and ALT (Alanine transaminase) \< 3 times normal * Creatinine clearance \> 50 mg/mL * Calcium \< 12 mg/dL (when corrected for level of serum albumin) * No known HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Inadequately controlled hypertension (defined as systolic blood pressure \[BP\] \> 150 mm Hg and/or diastolic BP \> 100 mm Hg on antihypertensive medications) * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association class II-IV congestive heart failure * Myocardial infarction or unstable angina within the past 6 months * Stroke or transient ischemic attack within the past 6 months * Significant vascular disease (e.g., aortic aneurysm or aortic dissection) * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Significant traumatic injury within the past 28 days * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * Serious, non-healing wound, ulcer, or bone fracture * Proteinuria at screening as demonstrated by either of the following: * Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening * Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein \> 1g * Known hypersensitivity to any component of bevacizumab PRIOR CONCURRENT THERAPY: * No prior systemic treatment for metastatic papillary RCC * At least 4 weeks since prior palliative radiotherapy of painful areas * More than 28 days since prior major surgical procedure or open biopsy * No concurrent major surgical procedure * More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device * Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease
References
Publications (0)
Data not yet available
No reference posted for this study.