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Non-small Cell Lung Cancer (NSCLC)Phase 2NCT00227019

Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

A Phase 2 study testing Bevacizumab, Pemetrexed and Vitamin B12 in people with Non-small Cell Lung Cancer (NSCLC) and Lung Cancer, run by Heather Wakelee at 4 sites in United States.

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 evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Pemetrexed and Vitamin B12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesUnited States
Study dates
Mar 2006to Dec 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced stage NSCLC excluding squamous cell histology with measurable or evaluable disease.
  • Stable brain metastases required, no longer requiring active therapy such as steroid medications, which have been previously treated with radiation or surgery or both and have been documented to be stable on repeat imaging done at least one month after completion of therapy.
  • Prior therapy with one standard doublet front-line regimen for NSCLC (platinum containing)
  • Life expectancy of at least 3 months
  • ECOG Performance status 0-1
  • Age 18 or higher
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  • Use of effective means of contraception (men and women) in subjects of child-bearing potential
  • Ability/willingness to comply with vitamin supplementation including vitamin B 12 and folic acid started at least 1 week before first dose of pemetrexed and continued for at least 3 weeks after last dose
  • Ability/willingness to take dexamethasone the day before, of and after pemetrexed administration
  • Drainage of any clinically significant effusion
  • Ability to sign informed consent

Who cannot join

  • Treatment with more than one prior chemotherapy regimen (unless one regimen was stopped for toxicity reasons with a different regimen replacement regimen started immediately and patient completed only 4-6 total cycles of first-line treatment. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will also be allowed.
  • Prior treatment with pemetrexed or bevacizumab
  • Prior chemotherapy within 28 days (6 weeks for BCNU, CCNU or mitomycin-C)
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
  • Concomitant chemotherapy, radiotherapy or investigational agents
  • Uncontrolled effusion (large pleural or peritoneal effusion or small/moderate effusion which requires drainage for symptom management)
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  • Evidence of bleeding diathesis or coagulopathy
  • Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
  • Pregnant (positive pregnancy test) or lactating women
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
  • Urine protein:creatinine ratio greater than or equal to 1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture
  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist
  • History of hemoptysis (bright red blood of 1/2 teaspoon or more)
  • Neutrophils < 1.5 x 10^9/ L
  • Hemoglobin <10.0 g/dl
  • Platelets <100 x 10^9/ L
  • Serum glutamic oxaloacetic transaminase (SGOT/ AST) or serum glutamic pyruvic transaminase (SGPT/ ALT) > 2.5 times upper limits of normal
  • Creatinine > 1.5 times upper limits of normal
  • Significant co-morbidities including:
  • Blood pressure of greater than 150/100 mmHg
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: Phase II Trial of Bevacizumab in Combination With Pemetrexed as Second Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer (NSCLC) (Excluding Squamous Cell Carcinoma)

This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Read the detailed description

Brain metastases are a common complication of advanced non-small-cell lung cancer (NSCLC) both at initial presentation and at the time of disease progression. Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier. However, as survival has improved, some trials have included such patients, often finding similar benefit to patients with metastatic disease elsewhere.

Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor, has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC. This drug is normally used as a first line chemotherapy. Pemetrexed is a multi-targeted anti-folate agent,which is approved for use in first-line (with platinum), maintenance, and second-line treatment of advanced nonsquamous NSCLC. Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases, a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases

Being tested
Bevacizumab, Pemetrexed, Vitamin B12, Folate, Dexamethasone
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg, IV over 10 minutes every 3 weeks

  • PemetrexedDrug

    Also called Alimta

    500 mg/m²; IV over 10 minutes every 3 weeks

  • Vitamin B12Drug

    Also called cobalamin, Vit B12

    1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed

  • FolateDrug

    Also called folacin, Folic acid, pteroyl-L-glutamic acid, pteroyl-L-glutamate

    350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose

  • DexamethasoneDrug

    Also called Decadron

    4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Study groups in NCT00227019
Study groupRoleWhat they receive
bevacizumab+ pemetrexedExperimentalpemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone
Receives: Drug: Bevacizumab; Drug: Pemetrexed; Drug: Vitamin B12; Drug: Folate; Drug: Dexamethasone

What is being measured

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

  1. Incidence of Central Nervous System (CNS) Hemorrhagic Events

    Number of events of brain or central nervous system (CNS) bleeding

    Measured: 18 months

Secondary outcomes (2)

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.

    Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).

    Measured: 18 months

  2. Overall Survival (OS)

    Overall Survival (OS) is defined as the duration of time from start of treatment to deat.

    Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).

    Measured: 18 months

Timeline

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

  1. First posted27 Sep 2005 (estimated)
  2. Study startMar 2006
  3. Primary completionNov 2010
  4. Study completionDec 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227019
Sponsor's protocol ID
IRB-00892
Other IDs
95913, LUN0014
Status last verified
Jan 2017
First submitted
8 Sep 2005
Last updated
6 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Pemetrexed and Vitamin B12 in people with Non-small Cell Lung Cancer (NSCLC) and Lung Cancer, run by Heather Wakelee at 4 sites in United States.

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 11 inclusion and 29 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 6 Mar 2017). 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?

Incidence of Central Nervous System (CNS) Hemorrhagic Events (time frame: 18 months). 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 NCT00227019.

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 6 Mar 2017.

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