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Adenocarcinoma of the LungPhase 2/3NCT00021060

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

A Phase 2/3 study testing paclitaxel, carboplatin 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.

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

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
paclitaxel, carboplatin and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
842 participants
Where
1 siteUnited States
Study dates
Aug 2002to Sep 2006
Phase
Phase 2/3
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

  • Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma; mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible; cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
  • Patients must have advanced NSCLC (stage IIIB with malignant pleural effusion or stage IV or recurrent disease)
  • Patients must have measurable or non-measurable disease
  • ECOG performance status 0 or 1
  • Patients must not have known central nervous system (CNS) metastases; a head CT is required within 4 weeks prior to study entry; (MRIs are also acceptable)
  • Patients must not have received prior systemic chemotherapy at any time
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  • ANC >= 1500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin =< 1.5 mg/dl
  • Transaminases =< 5 x ULN
  • Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
  • Urine dipstick for proteinuria of less than 1+ (i.e., either 0 or trace); if urine dipstick is >= 1+ then a 24 hour urine for protein must demonstrate < 500 mg of protein in 24 hours to allow participation in the study; note: urinalysis is also acceptable
  • Patients must have INR =< 1.5 and a PTT no greater than upper limits of normal within 1 week prior to randomization
  • Pregnant and lactating women are excluded from the study
  • Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
  • Patients must not have had immuno, hormonal or radiation therapy within 3 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 3 weeks earlier are ineligible
  • Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must have no history of thrombotic or hemorrhagic disorders
  • Patients with history of hypertension must be well-controlled (< 150/100) on a stable regimen of anti-hypertensive therapy
  • Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed
  • Patients must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 21 days prior to starting treatment
  • Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation of venous access devices is allowed; caution should be taken on treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding
  • Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2 teaspoon or more) will be excluded from this trial

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Randomized Phase II/III Trial of Paclitaxel Plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients With Advanced Nonsquamous NSCLC

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess toxicity and survival in patients with advanced or metastatic (stage IIIB pleural effusion/IV), nonsquamous histology non-small cell lung cancer (NSCLC) treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) II. To assess response rates and time to progression in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) III. To assess overall survival in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III) IV. To assess response rates, time to progression, and toxicity in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), non-squamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III)

SECONDARY OBJECTIVES:

  1. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with carboplatin-Taxol with or without anti-VEGF monoclonal antibody (MAb).

II. To determine if pre-treatment plasma VEGF is of prognostic value in advanced NSCLC.

III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin), reflective of chemotherapy or anti-VEGF induced endothelial damage, are useful markers in assessing response to carboplatin/Taxol +/- anti-VEGF therapy.

IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor (bFGF) is of prognostic value or predictive of response to therapy.

OUTLINE: This is a randomized study. Patients are stratified according to measurable disease (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.

ARM II: Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1.

Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.

Being tested
paclitaxel, carboplatin, bevacizumab, 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.

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • bevacizumabBiological

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

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00021060
Study groupRoleWhat they receive
Arm I (paclitaxel and carboplatin)ExperimentalPatients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: paclitaxel; Drug: carboplatin; Other: laboratory biomarker analysis
Arm II (paclitaxel, carboplatin, and bevacizumab)ExperimentalPatients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: paclitaxel; Drug: carboplatin; Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

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

  1. Survival

    Analyses will be based on repeated confidence intervals for the hazard ratio, using O'Brien-Fleming stopping boundaries corresponding to a one-sided, 2.5% overall type I error. The confidence interval will be calculated on the log hazard ratio scale based on the log hazard ratio and variance estimates from the Cox partial likelihood, using the large sample normal approximation, and then the interval will be transformed to the hazard ratio scale.

    Measured: Up to 5 years

  2. Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    After each episode, the two treatment arms will be compared with respect to these events using a Fisher's exact test with two sided p-value 0.05.

    Measured: Up to 5 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionSep 2006

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
842 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021060
Sponsor's protocol ID
NCI-2012-02947
Other IDs
E4599, U10CA021115, CDR0000068744
Status last verified
Feb 2013
First submitted
11 Jul 2001
Last updated
27 Feb 2013
Results posted
No

Publications

  • Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

    PubMed 17167137

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing paclitaxel, carboplatin 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 23 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: finished, as of the sponsor's last update on 27 Feb 2013. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Survival (time frame: Up to 5 years). The study lists 2 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 NCT00021060, 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 27 Feb 2013.

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