Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLC

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Bevacizumab; Docetaxel

Criteria

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)