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

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT01368848
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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 — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

First listed
Jun 8, 2011
Start date
Apr 30, 2010
Status verified
Aug 2013
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Response Rate [ Time Frame: 4 years ]

Related Studies