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Non-small Cell Lung Cancer Stage IIIBPhase 2NCT00766246

Phase II Avastin Trial for Stage IIIB/IV NSCLC

A Phase 2 study testing bevacizumab, docetaxel and carboplatin in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Pharmatech.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab, docetaxel and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
No sites listed yet
Study dates
Oct 2008to Apr 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histologically or cytologically confirmed stage IIIB with malignant pleural effusion or stage IV NSCLC except squamous-cell carcinoma
  • Measurable disease defined by RECIST
  • Adequate organ function:
  • Absolute neutrophil count ≥ 1.5 x 10(9)/L
  • Hemoglobin ≥ 9.0 g/dL
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  • Platelets ≥ 100 x 10(9)/L
  • Hepatic enzyme levels: AST and ALT and Alkaline Phosphatase must be within range allowing for eligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used according to table listed in the protocol
  • Bilirubin ≤ ULN
  • Serum Creatinine ≤ 1.5 mg/dL (or creatinine clearance ≥ 60mL/min)
  • Urine protein/creatinine ratio < 1.0 OR urine dipstick for proteinuria < 2 + (patients discovered to have ≥ 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible)
  • INR ≤ 1.5
  • PTT ≤ ULN
  • ECOG Performance Status 0-1
  • Estimated survival of ≥ 12 weeks
  • Provide written informed consent

Who cannot join

  • Prior chemotherapy for advanced NSCLC
  • Neoadjuvant or adjuvant treatment within six (6) months of registration
  • Prior radiation therapy within three (3) weeks of registration; all side effects must have resolved by registration
  • Prior treatment with an investigational or marketed agent that acts by antiangiogenesis mechanisms
  • Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels unless treated with palliative radiation
  • Brain metastases or leptomeningeal disease, except for patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least one (1) month prior to registration
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  • History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode) within three (3) months of registration unless definitively treated with surgery, radiation, arteriographic embolization, or endobronchial interventions at least four (4) weeks prior to registration
  • Presence of cavitory lesion
  • Presence of squamous histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable)
  • Peripheral neuropathy > grade 1
  • Major surgery, open biopsy or significant traumatic injury within four (4) weeks of registration or anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures, fine needle aspirations or core biopsies within one (1) week prior to registration
  • Current, ongoing therapeutic anticoagulation with full-dose warfarin or its equivalent
  • Current or recent (within ten [10] days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other NSAIDs with anti-platelet activity or treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazol (Pletal)
  • History of prior malignancy within the past three (3) years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on two successive evaluations, at least three (3) months apart, with the most recent evaluation no more than four (4) weeks prior to registration
  • History of serious systemic disease including:
  • Unstable angina, New York Heart Association (NYHA) ≥ Grade II or congestive heart failure
  • Inadequately controlled hypertension (blood pressure >150/100 mmHg while taking antihypertensive medications)
  • Unstable symptomatic arrhythmia requiring medication
  • Myocardial infarction within six (6) months prior to registration
  • Stroke within six (6) months prior to registration
  • Transient ischemic attack within six (6) months prior to registration
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within six (6) months prior to registration
  • Clinically significant peripheral vascular disease or evidence of bleeding, diathesis (prone to bleeding) or coagulopathy
  • Active systemic bacterial, fungal or viral infection, including known HCV and HIV
  • Pregnancy or women who are breast-feeding; women of child-bearing potential and non-vasectomized men must agree to use effective methods of birth control during and three (3) months following treatment period and women of child-bearing potential must have a negative pregnancy test
  • History of severe hypersensitivity reaction to docetaxel or any other drugs formulated with polysorbate 80
  • Any other medical condition, including mental illness or substance abuse, which in the judgment of the investigator, is likely to interfere with a patient's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
  • Use of any investigational agent within four (4) weeks prior to registration

About this study

Official title: A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).

Read the detailed description

This phase II clinical trial will address the issues of bevacizumab treatment duration and treatment safety as first-line therapy for patients with non-squamous NSCLC. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab. It is hypothesized that continuation of bevacizumab with pemetrexed as second-line treatment following progression will result in improved clinical outcomes for patients with NSCLC.

Keywords
Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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 administered in 21 day cycles on day 1 of each cycle for first-line and maintenance

  • docetaxelDrug

    Also called Taxotere

    75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment

  • carboplatinDrug

    Also called Paraplatin

    AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment

Study groups in NCT00766246
Study groupRoleWhat they receive
First-lineExperimentalCarboplatin, docetaxel, bevacizumab Open-label, single arm with treatment period up to 6 cycles. Patients completing a total of 2 to 6 cycles of first-line without disease progression will be eligible for maintenance.
Receives: Drug: bevacizumab; Drug: docetaxel; Drug: carboplatin
MaintenanceExperimentalBevacizumab Open-label, single arm with treatment period up to 18 cycles.
Receives: Drug: bevacizumab

What is being measured

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

  1. Progression-free survival (PFS) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC

    Measured: Duration of study

Secondary outcomes (5)

  1. Overall Survival (OS)

    Measured: Duration of the study

  2. Objective tumor response (objective response rate [ORR]) in second-line treatment

    Measured: Duration of the study

  3. Progression-free survival (PFS) in first-line and maintenance treatment

    Measured: Duration of the study

  4. Objective tumor response (objective response rate [ORR]) in first-line and maintenance treatment

    Measured: Duration of the study

  5. Treatment safety in first-line, maintenance and second-line treatment

    Measured: Duration of the study

Timeline

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

  1. First posted3 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2012
  4. Study completionApr 2012

Why it stopped: Withdrawal of funding support

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
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00766246
Sponsor's protocol ID
PSHCI 08-009
Status last verified
Apr 2016
First submitted
1 Oct 2008
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, docetaxel and carboplatin in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Pharmatech.

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 16 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: stopped early, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: Withdrawal of funding support). Results are not available in the source record.

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) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC (time frame: Duration of study). 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 NCT00766246.

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 19 Apr 2016.

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