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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
This study has been completed.
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025389
  Purpose

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 Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025389

Locations
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
Investigators
Study Chair: Ann M. Mauer, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068956, UCCRC-12653A, NCI-2655, OSU-0120
Study First Received: October 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025389     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Bevacizumab
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009