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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Sanofi

Roche Pharma AG

Information provided by:

Arbeitsgemeinschaft medikamentoese Tumortherapie

ClinicalTrials.gov Identifier:

NCT01368848

First received: June 7, 2011

Last updated: October 4, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 7, 2011
Last Updated Date	October 4, 2012
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 7, 2011)	Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01368848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 7, 2011)	Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Overall survival, defined as the duration of time from first study treatment until death from any cause. Duration of response [ Time Frame: 5 years ] [ Designated as safety issue: No ] Duration of response defined as timeframe from first response (CR or PR) until progression from best response.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	NSCLC
Intervention ^ICMJE	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 Other Name: Avastin Drug: 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 Drug: 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 Other Name: Taxotere
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01368848
Other Study ID Numbers ^ICMJE	AGMT_NSCLC 1, 2008-000765-33
Has Data Monitoring Committee	No
Responsible Party	Richard Greil, AGMT gemeinnützige GmbH
Study Sponsor ^ICMJE	Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators ^ICMJE	Sanofi Roche Pharma AG
Investigators ^ICMJE	Not Provided
Information Provided By	Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top