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

This study has been withdrawn prior to enrollment.
(Due to poor accrual of the study)
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00620971
First received: January 31, 2008
Last updated: April 8, 2010
Last verified: April 2010

January 31, 2008
April 8, 2010
January 2008
January 2011   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00620971 on ClinicalTrials.gov Archive Site
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Vinorelbine
    Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
    Other Name: Navelbine
  • Drug: Cisplatin
    Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
    Other Name: CDDP
  • Drug: Bevacizumab
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
    Other Name: Avastin
  • Drug: Docetaxel
    Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
    Other Name: Taxotere
  • Drug: Gemcitabine
    Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
    Other Name: Gemzar
  • Drug: Bevacizumab
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
    Other Name: Avastin
  • Drug: Cisplatin
    Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
    Other Name: CDDP
  • Experimental: 1
    NC/Avastin->DG/Avastin
    Interventions:
    • Drug: Vinorelbine
    • Drug: Cisplatin
    • Drug: Bevacizumab
    • Drug: Docetaxel
    • Drug: Gemcitabine
    • Drug: Bevacizumab
  • Experimental: 2
    DG/Avastin
    Interventions:
    • Drug: Docetaxel
    • Drug: Cisplatin
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
350
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00620971
CT/07.19
No
V.Georgoulias, Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
Hellenic Oncology Research Group
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP