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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025389
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A
Bevacizumab (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
Biological: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Procedure: conventional surgery
Procedure: neoadjuvant therapy

Primary Outcome Measures :
  1. Response Rate (complete and partial responses by RECIST) [ Time Frame: 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy:

  • More than 12 months


  • 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


  • 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


  • 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


  • 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


  • No hemoptysis
  • No pulmonary embolism


  • 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


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])


  • 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


  • 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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025389

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United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
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Study Chair: Ann M. Mauer, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT00025389    
Other Study ID Numbers: 12653A
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013
Keywords provided by University of Chicago:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors