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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01368848     History of Changes
Other Study ID Numbers: AGMT_NSCLC 1, 2008-000765-33
Study First Received: June 7, 2011
Last Updated: August 29, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on October 21, 2014