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Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01077713

A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer

A Phase 2 study testing bevacizumab [Avastin], cisplatin and gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 26 sites in Italy.

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 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
bevacizumab [Avastin], cisplatin and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
26 sitesItaly
Study dates
Feb 2010to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • adult patients, >=70 years of age;
  • inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
  • >=1 measurable lesion;
  • ECOG performance status 0-1.

Who cannot join

  • neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
  • radical radiotherapy with curative intent within 28 days prior to enrollment;
  • history of >=grade 2 hemoptysis in 3 months prior to enrollment;
  • evidence of CNS metastases;
  • current or recent (within 10 days of first dose of Avastin)use of aspirin (>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Italy26 sites

  • Study site

    Ancona, The Marches, 60121

  • Study site

    Avellino, Campania, 83100

  • Study site

    Aviano, Friuli Venezia Giulia, 33081

  • Study site

    Bergamo, Lombardy, 24128

  • Study site

    Bologna, Emilia-Romagna, 40139

  • Study site

    Catania, Sicily, 95100

  • Study site

    Catanzaro, Calabria, 88100

  • Study site

    Genoa, Liguria, 16149

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Milan, Lombardy, 20142

  • Study site

    Mirano, Veneto, 30035

  • Study site

    Monza, Lombardy, 20052

  • Study site

    Naples, Campania, 80131

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Padova, Veneto, 35128

  • Study site

    Perugia, Umbria, 06156

  • Study site

    Pesaro, The Marches, 61122

  • Study site

    Rho, Lombardy, 20017

  • Study site

    Rionero in Vulture, Basilicate, 85028

  • Study site

    Rome, Lazio, 00128

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00189

  • Study site

    Sondalo, Lombardy, 23039

  • Study site

    Sondrio, Lombardy, 23100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

  • Study site

    Viterbo, Lazio, 01100

Other trials in Italy

About this study

Official title: Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES

This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Being tested
bevacizumab [Avastin], cisplatin, gemcitabine

What participants receive

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

  • bevacizumab [Avastin]Drug

    7.5mg/kg iv on day 1 of each 3 week cycle

  • cisplatinDrug

    60mg/m2 on day 1 of each 3 week cycle

  • gemcitabineDrug

    1200mg/m2 on days 1-8 of each 3 week cycle

  • gemcitabineDrug

    1000mg/m2 on days 1-8 of each 3 week cycle

Study groups in NCT01077713
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bevacizumab [Avastin]; Drug: gemcitabine
2ExperimentalNot described
Receives: Drug: bevacizumab [Avastin]; Drug: cisplatin; Drug: gemcitabine

What is being measured

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

  1. Percentage of Participants Alive and Without Progressive Disease at Month 6

    Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.

    Measured: Month 6

Secondary outcomes (9)

  1. Percentage of Participants With Disease Progression or Death

    Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

    Measured: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

  2. Progression Free Survival (PFS)

    PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

    Measured: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

  3. Percentage of Participants Alive at 12 Months After Randomization

    Measured: 1 year

  4. Percentage of Participants Who Died

    Measured: From randomization to death or end of the study (up to 53 months)

  5. Overall Survival (OS)

    OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

    Measured: From randomization to death or end of the study (up to 53 months)

  6. Percentage of Participants by Best Overall Response

    Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

  7. Percentage of Participants With an Objective Response

    Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

    Measured: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

  8. Percentage of Participants With Disease Control

    Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

    Measured: Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

  9. Duration of Response (DoR)

    DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.

    Measured: Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

Timeline

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

  1. First posted1 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01077713
Sponsor's protocol ID
ML21868
Other IDs
2008-008739-27, 2008
Status last verified
Sep 2015
First submitted
9 Feb 2010
Last updated
8 Oct 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab [Avastin], cisplatin and gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 26 sites in Italy.

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 4 inclusion and 5 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 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Alive and Without Progressive Disease at Month 6 (time frame: Month 6). 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 NCT01077713.

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 8 Oct 2015.

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