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

NSCLC Clinical Trial

Official title:

Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368848
• Other study ID #: AGMT_NSCLC 1
• Secondary ID: 2008-000765-33
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: August 29, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Bevacizumab
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W -> Bevacizumab Q3W until progression
• Cisplatin
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W
• Docetaxel
3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging -> further 3 cycles BCD Q3W

Locations

Country	Name	City	State
Austria	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

Sponsors (3)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Roche Pharma AG, Sanofi

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	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.	4 years	Yes
Secondary	Progression free survival	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.	5 years	No
Secondary	Overall survival	Overall survival, defined as the duration of time from first study treatment until death from any cause.	5 years	No
Secondary	Duration of response	Duration of response defined as timeframe from first response (CR or PR) until progression from best response.	5 years	No