Status:
WITHDRAWN
Metronomic Docetaxel and Bevacizumab in Patients With Small Cell Lung Cancer
Lead Sponsor:
University Hospital of Crete
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of metronomic docetaxel and bevacizumab combination in patients with pretreated, advanced small cell lung cancer.
Detailed Description
Approximately 80% of the patients with localized SCLC and all of the patients with extensive SCLC will relapse after 1st line chemotherapy. For the chemo-resistant patients (eg those that have relapse...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, metastatic (stage IV) small cell lung cancer
- One previous chemotherapy regimen metastatic SCLC
- 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
- Second primary malignancy, except for non-melanoma skin 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)
- 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
- Serum Να+ \< 120 mg/dL
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00755157
Start Date
April 1 2008
End Date
August 1 2012
Last Update
October 7 2015
Active Locations (3)
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1
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece