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Lung CancerPhase 2NCT00323869

Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer

A Phase 2 study testing Bevacizumab, Gemcitabine and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer (NSCLC), run by Stanford University at 3 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

A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Gemcitabine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
3 sitesUnited States
Study dates
Jun 2006to Oct 2013
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

  • Age 18 or higher
  • Life expectancy of at least 3 months
  • ECOG Performance status 0 to 1
  • Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural effusion or Stage 4, excluding squamous cell histology, with measurable or evaluable disease
  • No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry)
  • Palliative radiotherapy to painful bony metastases is permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression
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  • Willingness to use appropriate contraception to avoid pregnancy during the study
  • Leukocytes ≥ 3,000/µL
  • Absolute neutrophil count ≥ 1,500/ µL
  • Platelets ≥ 100,000/ µL
  • Total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal
  • Creatinine: Within normal institutional limits
  • Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
  • Ability to sign informed consent

Who cannot join

  • Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed at least 6 months prior to study entry)
  • Known brain metastases
  • Prior treatment with bevacizumab
  • History of allergic reactions
  • Sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
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  • Concomitant chemotherapy, radiotherapy, or investigational agents
  • Evidence of bleeding diathesis
  • Coagulopathy
  • Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
  • Pregnant
  • Lactating
  • 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 within 7 days prior to day 0
  • Fine needle aspirations within 7 days prior to day 0
  • Core biopsies within 7 days prior to day 0
  • Urine protein: creatinine ratio ≥ 1.0 at screening
  • History of abdominal fistula within 6 months prior to Day 0
  • Gastrointestinal perforation within 6 months prior to Day 0
  • Intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound
  • Ulcer
  • Bone fracture
  • Lung carcinoma of squamous cell histology
  • Any histology in close proximity to a major vessel
  • 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)
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • New York Heart Association (NYHA) Grade 2 or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Another active malignancy except for non-melanoma skin cancers
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Palo Alto Healthcare System

    Palo Alto, California, 94304-1290

  • Santa Clara Valley Medical Center

    San Jose, California, 95128

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma)

A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Read the detailed description

This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.

Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.

Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • BevacizumabDrug

    Also called Avastin, C225, rhuMAb-VEGF

    Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody

  • GemcitabineDrug

    Also called Gemzar

    Nucleoside analog

  • CarboplatinDrug

    Also called Paraplatin, CBDCA

    Alkylating agent

Study groups in NCT00323869
Study groupRoleWhat they receive
Bevacizumab + carboplatin + gemcitabineExperimentalBevacizumab in combination with carboplatin and gemcitabine: •Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles. Carboplatin was administered before the gemcitabine infusion: •Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Bevacizumab was administered 1 hour after end of all chemotherapy infusions: •Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
Receives: Drug: Bevacizumab; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

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

  1. Progression-free Survival (PFS)

    Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.

    Measured: 18 months

Secondary outcomes (8)

  1. Response Rate (CR + PR + SD)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE

    Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.

    • Complete Response (CR) = disappearance of all target lesions
    • Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
    • Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
    • Stable Disease (SD): No significant effect, does not meet criteria for PR or PD.

    Measured: 6 weeks

  2. Overall Survival (OS)

    To evaluate the safety of the combination regimen.

    Measured: 36 months

  3. Partial Response (PR)

    Number of subjects with PR per RECIST criteria

    Measured: 6 weeks

  4. Complete Response (CR)

    Number of subjects with CR per RECIST criteria

    Measured: 6 weeks

  5. Stable Disease (SD)

    Number of subjects with SD per RECIST criteria

    Measured: 6 weeks

  6. Time-to-First Event

    Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation

    Measured: 18 months

  7. Overall Survival (OS) at 12 Months

    Number of subjects surviving 1 year after treatment initiation

    Measured: 12 months

  8. Overall Survival (OS) at 24 Months

    Number of subjects surviving 2 years after treatment initiation

    Measured: 24 months

Timeline

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

  1. First posted10 May 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionOct 2013
  4. Study completionOct 2013

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323869
Sponsor's protocol ID
IRB-03730
Other IDs
96655, AVF3576s, LUN0013, NCT00323869
Status last verified
Jul 2016
First submitted
8 May 2006
Last updated
7 Sep 2016
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Clement-Duchene C, Krupitskaya Y, Ganjoo K, Lavori P, McMillan A, Kumar A, Zhao G, Padda S, Zhou L, Pedro-Salcedo MS, Colevas AD, Wakelee HA. A phase II first-line study of gemcitabine, carboplatin, and bevacizumab in advanced stage nonsquamous non-small cell lung cancer. J Thorac Oncol. 2010 Nov;5(11):1821-5. doi: 10.1097/JTO.0b013e3181f1d23c.

    PubMed 20881641

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Gemcitabine and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer (NSCLC), run by Stanford University at 3 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 15 inclusion and 36 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 27 Jul 2016). 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?

Progression-free Survival (PFS) (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 NCT00323869, 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 7 Sep 2016.

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