Overview

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