AzTrials
AzTrials

Lung CancerPhase 2NCT00025389

Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

A Phase 2 study testing bevacizumab, carboplatin and paclitaxel in people with Lung Cancer, run by University of Chicago at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
bevacizumab, carboplatin and paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
Nov 2001to Aug 2007
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer
  • Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1)
  • Potentially resectable disease
  • No large central primary tumors in proximity to significant blood vessels
  • No bronchoscopically evident endobronchial tumors
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy:

  • More than 12 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No history of an inherited bleeding disorder
  • No inherited predisposition to a hypercoagulable state
  • No clinically evident hypercoagulable state or bleeding diathesis

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN
  • INR less than 1.5
  • PTT less than 36 seconds

Renal:

  • Creatinine less than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min
  • No nephrotic syndrome
  • Urine protein no greater than 0.5 g/24 hours

Cardiovascular:

  • No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment
  • No uncompensated coronary artery disease
  • No myocardial infarction within the past 6 months
  • No clinically significant or severe peripheral vascular disease
  • No inherited predisposition to thrombosis
  • No deep venous or arterial thrombosis
  • No symptomatic congestive heart failure
  • No unstable angina pectoris within the past 6 months
  • No cardiac arrhythmia
  • No transient ischemic attack within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No other arterial thromboembolic event within the past 6 months

Pulmonary:

  • No hemoptysis
  • No pulmonary embolism

Other:

  • No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness or social situation that would preclude study compliance
  • No significant traumatic injury within the past 28 days
  • No uncontrolled concurrent illness
  • No ongoing or active infection
  • No serious, non-healing wound, ulcer, or bone fracture
  • No other active malignancy
  • No requirement for full-dose anticoagulation or thrombolytic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for this cancer
  • No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])

Chemotherapy:

  • No prior chemotherapy for this cancer
  • Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled

Endocrine therapy:

  • No prior endocrine therapy for this cancer

Radiotherapy:

  • No prior radiotherapy for this cancer
  • Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled
  • No concurrent radiotherapy

Surgery:

  • Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed
  • At least 28 days since prior major surgical procedure or open biopsy

Other:

  • No other concurrent investigational agents
  • No other concurrent anticancer investigational or commercial agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase 2 Study Of Neoadjuvant rhuMAb VEGF (Bevacizumab) In Combination With Paclitaxel And Carboplatin In Surgically Resectable Non-Small Cell Lung Cancer

RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin.
  • Determine the pathologic complete response rate in patients treated with this regimen.
  • Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen.
  • Determine the safety and toxicity of this regimen in these patients.

OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1.

Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy.

Patients are followed within 3 months.

PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study.

Conditions
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
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.

Study groups in NCT00025389
Study groupRoleWhat they receive
Arm AExperimentalBevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab
Receives: Biological: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Procedure: neoadjuvant therapy

What is being measured

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

  1. Response Rate (complete and partial responses by RECIST)

    Measured: 4 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 startNov 2001
  3. Primary completionDec 2005
  4. Study completionAug 2007

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025389
Sponsor's protocol ID
12653A
Other IDs
UCCRC-12653A, NCI-2655, OSU-0120
Status last verified
Feb 2013
First submitted
11 Oct 2001
Last updated
11 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, carboplatin and paclitaxel in people with Lung Cancer, run by University of Chicago at 2 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?

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 11 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 2 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?

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?

Response Rate (complete and partial responses by RECIST) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Feb 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in