Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

Phase 2

Completed

• Conditions: NSCLC

• Registration Number: NCT01368848
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.
• Previous radiotherapy.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response Rate	4 years	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

Name	Time	Method
Progression free survival	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	5 years	Overall survival, defined as the duration of time from first study treatment until death from any cause.
Duration of response	5 years	Duration of response defined as timeframe from first response (CR or PR) until progression from best response.

Trial Locations

Locations (3)

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Vorarlberg, Austria

Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie; 🇦🇹 Innsbruck, Tirol, Austria

Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III; 🇦🇹 Salzburg, Austria