Non-small-cell Lung Cancer
Conditions
Keywords
Cancer, NSCLC, Docetaxel, Bevacizumab
Brief summary
This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (NSCLC).
Detailed description
Docetaxel is and an effective cytotoxic agent in \> 1st line treatment of advanced or metastatic non small cell lung cancer (NSCLC). Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of docetaxel and bevacizumab as 2nd or 3rd line treatment of NSCLC.
Interventions
DRUGDocetaxel
Docetaxel at the dose of 75 mg/m2 IV on days 1 every 3 weeks for 6 consecutive cycles.
DRUGBevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Sponsors
Hellenic Oncology Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
| Overall Survival | 1 year |
| Quality of life assessment | Assessment every two cycles |
| Toxicity profile | Assessment every two cycles |
Countries
Greece
Outcome results
None listed