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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01368848
First Posted: June 8, 2011
Last Update Posted: August 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sanofi
Roche Pharma AG
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
  Purpose
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.

Condition Intervention Phase
NSCLC Drug: Bevacizumab Drug: Cisplatin Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 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:
  • Progression free survival [ Time Frame: 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 [ Time Frame: 5 years ]
    Overall survival, defined as the duration of time from first study treatment until death from any cause.

  • Duration of response [ Time Frame: 5 years ]
    Duration of response defined as timeframe from first response (CR or PR) until progression from best response.


Enrollment: 7
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368848


Locations
Austria
Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie
Innsbruck, Tirol, Austria, 6020
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria, 6806
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Salzburg, Austria, 5020
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Sanofi
Roche Pharma AG
  More Information

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01368848     History of Changes
Other Study ID Numbers: AGMT_NSCLC 1
2008-000765-33 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 8, 2011
Last Update Posted: August 30, 2013
Last Verified: August 2013

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
AGMT
NSCLC
non-small cell lung cancer
bevacizumab
Avastin
Cisplatin
Docetaxel
Taxotere
Inoperable
stages IIIB and IV

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Bevacizumab
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action