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Completed

NCT Number: NCT01368848

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

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.

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Key information

Conditions

NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III, Salzburg, State of Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Avastin

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

Other names: Taxotere

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Overall survival

    Time frame: 5 years

    Overall survival, defined as the duration of time from first study treatment until death from any cause.

  3. Duration of response

    Time frame: 5 years

    Duration of response defined as timeframe from first response (CR or PR) until progression from best response.

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Roche Pharma AG
  • Sanofi

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2011
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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