Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00620971
First received: January 31, 2008
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Vinorelbine
Drug: Cisplatin
Drug: Bevacizumab
Drug: Docetaxel
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 77
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
Experimental: 2
DG/Avastin
Drug: Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: Taxotere
Drug: Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
Other Name: CDDP
Drug: Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other Name: Avastin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00620971

Locations
Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
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
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, Greece
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00620971     History of Changes
Other Study ID Numbers: CT/07.19
Study First Received: January 31, 2008
Last Updated: June 24, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Non Small Cell Lung Cancer
Cisplatin
VInorelbine
Docetaxel
Gemcitabine
Bevacizumab

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Cisplatin
Docetaxel
Gemcitabine
Vinblastine
Vinorelbine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 20, 2014