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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (complete and partial responses by RECIST)

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Ann M. Mauer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

August 2007

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240