Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

June 24, 2014 updated by: Hellenic Oncology Research Group

Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.

Study Type

Interventional

Enrollment (Actual)

77

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

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital, Medical Oncology Unit
      • Athens, Greece
        • Air Forces Military Hospital, Dep of Medical Oncology
      • Athens, Greece
        • IASO" General Hospital of Athens, 1st Dep of Medical Oncology
      • Athens, Greece
        • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
      • Athens, Greece
        • Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC
  • Performance status (WHO) 0-1
  • Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min)

  • No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed

    --Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields

  • Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
  • Patient able to take oral medication
  • Absence of active CNS disease
  • Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available
  • Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Women of child-bearing age unable or unwilling to take effective contraceptive measures
  • Active CNS disease, brain metastases, or leptomeningeal involvement
  • Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0)
  • Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months
  • Active infection, requiring IV antibiotic treatment, within the previous 2 weeks
  • Long-term oxygen therapy
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
  • Radiotherapy within the previous 4 weeks
  • Previous radiotherapy to the only measurable lesion
  • Concurrent treatment with other anti-cancer drug
  • Uncontrolled hypercalcemia
  • Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or equivalent) for more than one month

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
NC/Avastin->DG/Avastin
Drug: Vinorelbine
Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
Other Names:
  • Navelbine
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
Other Names:
  • CDDP
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
Other Names:
  • Avastin
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Names:
  • Taxotere
Drug: Gemcitabine
Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
Other Names:
  • Gemzar
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other Names:
  • Avastin
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Names:
  • CDDP
Experimental: 2
DG/Avastin
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
Other Names:
  • CDDP
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
Other Names:
  • Avastin
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Names:
  • Taxotere
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other Names:
  • Avastin
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Names:
  • CDDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Tumor Progression
Time Frame: 1-year
1-year
Overall Survival
Time Frame: 1 year
1 year
Quality of life assessment
Time Frame: Assessment every two cycles
Assessment every two cycles

Collaborators and Investigators

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

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/07.19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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