Clinical trial · Interventional
Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer
A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
NCT00755170CI-TRIAL-00024144completedPhase 2ClinicalTrials.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)
This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung 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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Vinorelbine metronomic + bevacizumab
- interventionNames
- Drug: Vinorelbine
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment on each cycle
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed, metastatic (stage IV) non small cell lung cancer * One previous platinum based chemotherapy regimen with or without taxanes for metastatic NSCLC * Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm * Age ≥ 18 years * Performance status (WHO) 0-2 * Life expectancy of at least 12 weeks * Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit) * Patients must be able to understand the nature of this study * Written informed consent Exclusion Criteria: * Second primary malignancy, except for non-melanoma skin cancer. Pregnant or lactating women * Any serious, uncontrolled comorbidity on the investigator's judgment * Uncontrolled infection * Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0) * Brain metastases, except if radiated and asymptomatic * Radiotherapy within the previous 4 weeks * Previous radiotherapy to the only measurable lesion * Proteinuria ≥ 500 mgr of protein daily * Hemoptysis \> 10 cc per event * Clinically significant hematemesis * Centrally located lesion or in contact with major vessels * Pulmonary lesion with cavitation * Documented hemorrhagic diathesis or coagulation disorder * Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension) * Thrombotic event within the previous 6 months * Concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents * Concurrent treatment with other anti-cancer drug * Major surgical procedure within the previous 4 weeks * Serum Να+ \< 120mg/dL
References
Publications (0)
Data not yet available
No reference posted for this study.