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Non Small Cell Lung CancerNCT01934465

Bevacizumab Plus Chemotherapy for Advanced Non Small Cell Lung Cancer Patients as 1st Line Treatment

An observational study of Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 8 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

Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
How many people
300 participants
Where
8 sitesGreece
Study dates
Feb 2010to Dec 2013
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Clinics for cancer prevention

Who may be able to join

  • Signed informed consent prior to initiation of any trial-specific procedure or treatment
  • Ability to comply with the protocol
  • Histologically or cytologically (sample to be obtained by biopsy or bronchoscopy) confirmed non-squamous NSCLC (locally recurrent or metastatic) per investigator assessment
  • At least 1 unidimensionally measurable lesion meeting RECIST criteria
  • No prior first line treatment for metastatic colorectal cancer
  • Age ≥18 years
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  • ECOG performance status ≤2
  • Adequate haematological, renal and hepatic function
  • Urine protein <2+ (dipstick)
  • International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN within 7 days prior to randomization, unless there is prophylactic use of anti-coagulation
  • Patients with asymptomatic treated brain metastases are eligible for trial participation. Patients must complete treatment for brain metastases (radiotherapy with or without surgery, or stereotactic radiosurgery), including steroids, at least 28 days prior to randomization. Treatment with anticonvulsants at the time of randomization (i.e. ≥ 28 days) is allowed as long as the anti-convulsant is at a stable dose)
  • Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as >2 years after last menstruation or surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonspirals], sexual abstinence or vasectomized partner) during the trial and for a period of at least 6 months following the last administration of trial drug(s).Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the trial
  • Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonspirals], sexual abstinence or prior vasectomy) during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Who cannot join

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • History of hemoptysis ≥ grade 2 (defined as bright red blood of at least 2.5 mL) within 3 months prior to randomization
  • Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during trial treatment
  • Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
  • Evidence of tumor invading or abutting a major blood vessel (e.g., pulmonary artery or superior vena cava) on imaging
  • Radiotherapy to any site for any reason within 28 days prior to randomization. Palliative radiotherapy to bone lesions within 14 days prior to randomization is allowed
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  • Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose (i.e. therapeutic dose) oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
  • History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding
  • Active gastrointestinal bleeding
  • Inadequately controlled hypertension (blood pressure: systolic > 150 mmHg and/or diastolic > 100 mmHg) within 28 days prior to randomization or history of hypertensive crisis or hypertensive encephalopathy
  • Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident [CVA] or myocardial infarction within 6 months prior to randomization, unstable angina, congestive heart failure [CHF] New York Heart Association [NYHA] Class ≥ II, or serious cardiac arrhythmia), that is uncontrolled by medication or may interfere with administration of trial treatment
  • Non-healing wound, active peptic ulcer or untreated bone fracture
  • History of abdominal fistula, gastrointestinal perforation or intra abdominal abscess within 6 months prior to randomization.
  • Treatment with any other investigational agent within 28 days prior to randomization. Patients in the follow-up phase of 1st-line trials who fulfill all eligibility criteria may be enrolled in this trial if the 1st-line protocol allows bevacizumab-based treatment in the follow-up phase
  • Known hypersensitivity to bevacizumab or any of its excipients, or any of the SOC agents foreseen
  • Malignancy other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, and ductal carcinoma in situ (DCIS) treated surgically with curative intent
  • Evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational or SOC drug used in this study or puts the patient at higher risk for treatment-related complications

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Greece8 sites

  • University General Hospital of Alexandroupolis, Dept. of Medical Oncology

    Alexandroupoli

  • "IASO" General Hospital of Athens

    Athens

  • 401 Military Hospital of Athens

    Athens

  • Air Forces Military Hospital of Athens

    Athens

  • University Hospital of Crete, Dep of Medical Oncology

    Heraklion, Crete

  • State General Hospital of Larissa, Dep of Medical Oncology

    Larissa

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

    Piraeus

  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

    Thessaloniki

Other trials in Greece

About this study

Official title: Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively and Prospectively as First Line Treatment for Patients With Advanced or Metastatic Non Small Cell Lung Cancer. Assessment of Toxicity, Compliance and Survival of Patients.

Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer.

All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung Cancer.

Read the detailed description

In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, progression free survival and estimation of overall survival

Keywords
NSCLC, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line
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.

Study groups in NCT01934465
Study groupRoleWhat they receive
Avastin regimensPatients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)

What is being measured

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

  1. Number of Participants with AE

    In this observational study investigators are going to assess standard schedules in which administrations were every 3 weeks.

    Measured: Every 3 weeks up to 18 weeks

Secondary outcomes (3)

  1. Number of Participants with Response Rate

    In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks

    Measured: Disease evaluation at Week 6

  2. Percentage of Patients with Progression Free Survival

    Measured: 1 year

  3. Patients Overall Survival

    Measured: 1 year

Timeline

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

  1. First posted4 Sep 2013 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01934465
Sponsor's protocol ID
CT/10.11
Status last verified
Oct 2014
First submitted
30 Aug 2013
Last updated
24 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Matikas A, Kentepozidis Nu, Ardavanis A, Vaslamatzis M, Polyzos A, Emmanouilides Ch, Katsaounis P, Koinis F, Xynogalos S, Christopoulou A, Ziras N, Tegos T, Prinarakis E, Hatzidaki D, Georgoulias V, Kotsakis A; HORG's Lung Cancer Working Group. Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG). Cancer Chemother Pharmacol. 2016 Aug;78(2):369-76. doi: 10.1007/s00280-016-3094-7. Epub 2016 Jun 22.

    PubMed 27335027

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 8 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 13 inclusion and 17 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 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

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?

Number of Participants with AE (time frame: Every 3 weeks up to 18 weeks). 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 NCT01934465, 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 24 Oct 2014.

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