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

August 29, 2013 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6806
        • Landeskrankenhaus Feldkirch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
Overall survival
Time Frame: 5 years
Overall survival, defined as the duration of time from first study treatment until death from any cause.
5 years
Duration of response
Time Frame: 5 years
Duration of response defined as timeframe from first response (CR or PR) until progression from best response.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Sanofi
Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_NSCLC 1
  • 2008-000765-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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