Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (NSCLC).

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

Details

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed,

• Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC

• At least one and no more than two previous chemotherapy regimens for advanced - or 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 and give written informed consent

Exclusion Criteria:

• Previous therapy with docetaxel

• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical 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)

• Symptomatic neuropathy > 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