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Adenocarcinoma of the LungPhase 1NCT00369551

Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

A Phase 1 study testing 3-dimensional conformal radiation therapy, paclitaxel and bevacizumab in people with Adenocarcinoma of the Lung and Bronchoalveolar Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

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

Official record
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Trial summary

This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-dimensional conformal radiation therapy, paclitaxel and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Jun 2006to Feb 2008
Phase
Phase 1
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

  • Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
  • The following subtypes are eligible:
  • Adenocarcinoma (including bronchoalveolar)
  • Large cell carcinoma (including giant and clear cell carcinomas)
  • Poorly differentiated carcinoma
  • No squamous cell histology
Show all 58Show fewer
  • Unresectable stage II-III disease
  • Tumor must not invade the trachea or major arterial or venous structures
  • Measurable or evaluable disease
  • Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
  • No evidence of CNS disease, including primary brain tumor or brain metastases
  • ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
  • Life expectancy > 6 months
  • Granulocyte count ? 1,500/mm³
  • Platelet count ? 100,000/mm³
  • Bilirubin < 1.25 times upper limit of normal (ULN)
  • AST < 2.5 times ULN
  • Creatinine normalOR creatinine clearance ? 60 mL/min
  • FEV_1 ? 1.0 liters
  • 24-hour urine protein < 1,000 mg (for patients with urine protein:creatinine ratio [by urine analysis] > 1.0)
  • No hemoptysis within the past 12 months (defined as bright red blood in sputum of > 1 teaspoon)
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of allergic reactions attributed to carboplatin or taxane
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 14 days
  • No clinically significant cardiovascular disease, including any of the following:
  • Cerebrovascular accident within the past 6 months
  • Uncontrolled hypertension
  • Myocardial infarction or unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Unstable angina pectoris
  • Clinically significant peripheral vascular disease
  • No known bleeding diathesis or coagulopathy
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No uncontrolled intercurrent illness including, but not limited to, the following:
  • Ongoing or active infection
  • Psychiatric illness or social situations that would limit study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
  • No HIV positivity
  • No prior chemotherapy
  • No prior epidermal growth factor receptor-targeted therapy
  • No prior vascular endothelial growth factor-targeted therapy
  • No prior chest radiotherapy
  • No major surgery or open biopsy within the past 14 days
  • No concurrent treatment with full-dose anticoagulation
  • Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
  • Daily dose of warfarin < 1 mg
  • INR < 1.5
  • No other concurrent investigational agents
  • No concurrent major surgical procedures
  • No other concurrent anticancer agents or therapies
  • No concurrent chronic treatment with aspirin (> 325 mg daily) or nonsteroidal anti-inflammatory agents
  • No dexamethasone as an antiemetic during chemoradiotherapy
  • No colony-stimulating factors during chemoradiotherapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer

This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest radiotherapy in patients with locally advanced non-small cell lung cancer.

II. Characterize the toxicity of this treatment regimen. III. Assess the clinical response to this treatment regimen. IV. Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen.

OUTLINE: This is an open-label, multicenter study.Induction therapy.

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.

Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After study completion, patients are followed periodically for 36 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
3-dimensional conformal radiation therapy, paclitaxel, bevacizumab, carboplatin, laboratory biomarker analysis
Medical subject headings
Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • 3-dimensional conformal radiation therapyRadiation

    Also called 3D conformal radiation therapy, 3D-CRT

    Undergo 3-dimensional conformal radiation therapy

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00369551
Study groupRoleWhat they receive
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)ExperimentalPatients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1. Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: 3-dimensional conformal radiation therapy; Drug: paclitaxel; Biological: bevacizumab; Drug: carboplatin; Other: laboratory biomarker analysis

What is being measured

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

  1. Safety and feasibility

    Measured: Up to 36 months

  2. In-field toxicity, defined as bleeding or perforation of the tracheobronchial or gastrointestinal structures within the radiation field

    Measured: Up to 36 months

  3. Clinical response

    Measured: Up to 36 months

  4. Correlation of levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response

    Measured: Up to 36 months

Timeline

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

  1. First posted29 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2008

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369551
Sponsor's protocol ID
NCI-2012-02718
Other IDs
NCI-2012-02718, UCCRC-14576A, CDR0000491998, NCI-7213, 14576A, 7213, P30CA014599, N01CM62201
Status last verified
Jan 2013
First submitted
24 Aug 2006
Last updated
6 Mar 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3-dimensional conformal radiation therapy, paclitaxel and bevacizumab in people with Adenocarcinoma of the Lung and Bronchoalveolar Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 58 inclusion and 0 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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. 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?

Safety and feasibility (time frame: Up to 36 months). The study lists 4 primary outcomes in all. 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 NCT00369551.

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 2014.

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