Clinical trial · Interventional
Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLC
First Line Treatment of Elderly Patients With Advanced or Metastatic NSCLC With Docetaxel and Bevacizumab
NCT02179567CI-TRIAL-00019226terminatedPhase 2ClinicalTrials.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): Terminated due to poor accrual
Summary
Brief summary (as posted)
The investigators propose to study the efficacy and safety of the combination of Docetaxel plus Bevacizumab in a Phase II trial of elderly subjects with 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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doc/Bev
- description
- Docetaxel/Bevacizumab
- interventionNames
- Drug: Docetaxel
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Disease evaluation at Week 9
Secondary outcomes (4)
- measure
- Disease control rate
- timeFrame
- Disease evaluation at Week 9
- description
- Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥70 years old * Cytologically or histologically documented NSCLC * Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion) * World Health Organisation (WHO) performance status 0-2 * Non-frail patients according to Comprehensive Geriatric Assessment * No prior chemotherapy * Life expectancy of at least 12 weeks * Serum bilirubin less than 1.5 times the upper normal limit * Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases * Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min * Neutrophil count more than 1.5x 109 /L * Platelet count more than 100x 109 /L * Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations. Exclusion Criteria: * Hemoptysis * Central nervous system metastases * Hemorrhagic diathesis or coagulopathy * Anticoagulation therapy; regular use of aspirin (\>325 mg/d), nonsteroidal anti-inflammatory agents, or other agents known to inhibit platelet function * Major surgery within 28 days before enrolment * Clinically significant cardiovascular disease * Medically uncontrolled hypertension * Radiological evidence of tumors invading or abutting major blood vessels * Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ) * Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
References
Publications (0)
Data not yet available
No reference posted for this study.