AzTrials
AzTrials

Non Small Cell Lung CancerPhase 2NCT00620971

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

A Phase 2 study testing Vinorelbine, Cisplatin and Bevacizumab in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Vinorelbine, Cisplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
9 sitesGreece
Study dates
Jan 2008to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Greece9 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

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

    Athens

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

    Athens

  • 401 Military Hospital, Medical Oncology Unit

    Athens

  • Air Forces Military Hospital, Dep of Medical Oncology

    Athens

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

    Athens

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

    Athens

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

    Athens

  • "Theagenion" Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this 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

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.

Read the 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.

Keywords
Non Small Cell Lung Cancer, Cisplatin, VInorelbine, Docetaxel, Gemcitabine, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinorelbineDrug

    Also called Navelbine

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

  • CisplatinDrug

    Also called CDDP

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

  • BevacizumabDrug

    Also called Avastin

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

  • DocetaxelDrug

    Also called Taxotere

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

  • GemcitabineDrug

    Also called Gemzar

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

  • BevacizumabDrug

    Also called Avastin

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

  • DocetaxelDrug

    Also called Taxotere

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

  • CisplatinDrug

    Also called CDDP

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

  • BevacizumabDrug

    Also called Avastin

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

Study groups in NCT00620971
Study groupRoleWhat they receive
1ExperimentalNC/Avastin->DG/Avastin
Receives: Drug: Vinorelbine; Drug: Cisplatin; Drug: Bevacizumab; Drug: Docetaxel; Drug: Gemcitabine
2ExperimentalDG/Avastin
Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

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

Secondary outcomes (3)

  1. Time to Tumor Progression

    Measured: 1-year

  2. Overall Survival

    Measured: 1 year

  3. Quality of life assessment

    Measured: Assessment every two cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620971
Sponsor's protocol ID
CT/07.19
Status last verified
Jun 2014
First submitted
31 Jan 2008
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25662596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Cisplatin and Bevacizumab in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.

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