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

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00620971

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Gemcitabine Docetaxel Gemcitabine hydrochloride Vinorelbine tartrate Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	350
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NC/Avastin->DG/Avastin	Drug: Vinorelbine Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles Drug: Cisplatin Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles Drug: Bevacizumab Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles Drug: Docetaxel Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles Drug: Gemcitabine Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles Drug: Bevacizumab Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
2: Experimental DG/Avastin	Drug: Docetaxel Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles Drug: Cisplatin Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles Drug: Bevacizumab Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Arms

Assigned Interventions

1: Experimental

NC/Avastin->DG/Avastin

Drug: Vinorelbine

Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles

Drug: Cisplatin

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles

Drug: Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles

Drug: Docetaxel

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

Drug: Gemcitabine

Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles

Drug: Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

2: Experimental

DG/Avastin

Drug: Docetaxel

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

Drug: Cisplatin

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles

Drug: Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620971

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations

Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athina Aggelidou, MD
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Maria Aggelidou, MD
Principal Investigator: Vassilis Xandrinos, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
401 Military Hospital, Medical Oncology Unit	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalambos Christophillakis, MD
Air Forces Military Hospital, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Kakolyris, MD
"Theagenion" Anticancer Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD

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 ( V.Georgoulias )
Study ID Numbers:	CT/07.19
Study First Received:	January 31, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00620971 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Non Small Cell Lung Cancer
Cisplatin
VInorelbine

Docetaxel
Gemcitabine
Bevacizumab

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Immunologic Factors
Bevacizumab
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Docetaxel
Vinorelbine

Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses

Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 06, 2009