Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
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Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.
The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
Secondary Outcome Measures :
Progression free survival [ Time Frame: 5 years ]
Progression free survival, defined as the duration of time from first study treatment until progression or death from any cause as documented by the investigator.
Overall survival [ Time Frame: 5 years ]
Overall survival, defined as the duration of time from first study treatment until death from any cause.
Duration of response [ Time Frame: 5 years ]
Duration of response defined as timeframe from first response (CR or PR) until progression from best response.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
At least 1 measurable lesion according to RECIST criteria
ECOG performance score 0 or 1
Age between 18 and 70 years
Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
History of haemoptysis
Evidence of tumour invading major blood vessels on imaging.
Previous neoadjuvant/adjuvant chemotherapy.
Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
Major surgical procedures within 4 weeks prior to study entry.
Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
Non-healing wound, active peptic ulcer or bone fracture.
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.