Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00753909
- Lead Sponsor
- Hellenic Oncology Research Group
- Brief Summary
This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, advanced non small cell lung cancer.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Carboplatin Paclitaxel/Carboplatin/Bevacizumab 1 Bevacizumab Paclitaxel/Carboplatin/Bevacizumab 1 Paclitaxel Paclitaxel/Carboplatin/Bevacizumab
- Primary Outcome Measures
Name Time Method Overall Response Rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
- Secondary Outcome Measures
Name Time Method Toxicity profile Toxicity assessment of each chemotherapy cycle Time to Tumor Progression 1-year Overall Survival 1 year
Trial Locations
- Locations (10)
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
🇬🇷Athens, Greece
401 Military Hospital of Athens
🇬🇷Athens, Greece
"Diabalkaniko" hospital, Thessaloniki
🇬🇷Thessaloniki, Greece
University Hospital of Heraklion, Dep of Medical Oncology
🇬🇷Heraklion, Creta, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
University General Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece
State General Hospital of Larissa, Dep of Medical Oncology
🇬🇷Larissa, Greece