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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Roche Pharma AG
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01368848
First received: June 7, 2011
Last updated: August 29, 2013
Last verified: August 2013

June 7, 2011
August 29, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01368848 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
NSCLC
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01368848
AGMT_NSCLC 1, 2008-000765-33
No
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
  • Sanofi
  • Roche Pharma AG
Not Provided
Arbeitsgemeinschaft medikamentoese Tumortherapie
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP