Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
The addition of bevacizumab to paclitaxel plus carboplatin in the 1st line treatment of
patients with advanced or metastatic non small cell lung cancer (NSCLC) 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. The combination of paclitaxel and carboplatin, administered every two
weeks, has a favorable toxicity profile. This study will evaluate the addition of
bevacizumab to a biweekly regimen of paclitaxel and carboplatin as 2nd or 3rd line therapy
for NSCLC
Inclusion Criteria:
- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB)
or metastatic (stage IV) non-squamous NSCLC
- Non-squamous histologic type
- 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 ≥ 9 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
- Written informed consent
Exclusion Criteria:
- Previous therapy with paclitaxel in combination with carboplatin
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate
Outcome Time Frame:
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Safety Issue:
No
Principal Investigator
Sofia Agelaki, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete
Authority:
Greece: National Organization of Medicines
Study ID:
CT/08.17
NCT ID:
NCT00753909
Start Date:
November 2008
Completion Date:
March 2013
Related Keywords:
- Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer
- Paclitaxel
- Carboplatin
- Bevacizumab
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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