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

NCT00620971 | Completed Phase 2

• 1 other identifier: CT/07.19
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Cisplatin; VInorelbine; Docetaxel; Gemcitabine; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

• Time to Tumor Progression

  1-year

• Overall Survival

  1 year

• Quality of life assessment

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

NC/Avastin-\>DG/Avastin

Drug: Vinorelbine; Drug: Cisplatin; Drug: Bevacizumab; Drug: Docetaxel; Drug: Gemcitabine

2

EXPERIMENTAL

DG/Avastin

Drug: Docetaxel; Drug: Cisplatin; Drug: Bevacizumab

Interventions

Vinorelbine DRUG

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

Also known as: Navelbine

1

Cisplatin DRUG

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

Also known as: CDDP

1

Bevacizumab DRUG

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

Also known as: Avastin

1

Docetaxel DRUG

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

Also known as: Taxotere

1

Gemcitabine DRUG

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

Also known as: Gemzar

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

• Kotsakis A, Kentepozidis N, Emmanouilidis Ch, Polyzos A, Agelidou A, Vaslamatzis M, Chandrinos V, Agelaki S, Vamvakas L, Kalbakis K, Katsaounis P, Stoltidis D, Nintos G, Hatzidaki D, Vetsika EK, Mavroudis D, Georgoulias V. Sequential administration of vinorelbine plus cisplatin and bevacizumab followed by docetaxel plus gemcitabine and bevacizumab compared to docetaxel plus cisplatin and bevacizumab regimen as first-line therapy for advanced or metastatic non-squamous non-small cell lung cancer: A multicenter randomized phase II trial of the Hellenic Oncology Research Group (HORG). Lung Cancer. 2015 Apr;88(1):57-62. doi: 10.1016/j.lungcan.2015.01.012. Epub 2015 Jan 23.

  PMID: 25662596 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Cisplatin; Bevacizumab; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

GR (9)