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A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer



- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung
cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.


- Determine the median and overall survival of patients treated with this regimen.

- Determine the safety profile of this regimen.

- Determine the time to treatment failure of patients treated with this regimen.

- Determine the pathologic response rate and the resectability rate in patients treated
with this regimen.

- Correlate vascular endothelial growth factor (VEGF) levels or expression with response
and survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60
minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days
for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant
or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with
standard radical mediastinal lymph node dissection.

NOTE: *Bevacizumab is only administered during courses 1 and 2.

After completion of study treatment, patients are followed periodically for 8 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer

- No squamous cell carcinoma

- No histology in close proximity to a major vessel

- Resectable stage IB-IIIA disease

- No CNS or brain metastases


- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Bilirubin normal

- Creatinine ≤ 1.5 mg/dL

- Urine protein:creatinine < 1.0

- Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)

- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST and ALT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after completion of study treatment

- Adequate pulmonary and cardiovascular function to tolerate surgical resection

- No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon)

- No existing peripheral neuropathy ≥ grade 1

- No known history of severe hypersensitivity reaction to drugs formulated with
polysorbate 80

- No history of serious systemic disease, including any of the following:

- Myocardial infarction within the past 6 months

- Uncontrolled hypertension (i.e., blood pressure > 150/110 mm Hg on medication)

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- Unstable symptomatic arrhythmia requiring medication

- Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or
paroxysmal supraventricular tachycardia) are eligible

- Clinically significant peripheral vascular disease (i.e., grade II or higher)

- No history of significant neurological or psychiatric condition

- No known active infection within the past 14 days

- No serious, nonhealing wound, ulcer, or bone fracture

- No evidence of bleeding diathesis or coagulopathy

- No stroke within the past 6 months

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No other serious illness or medical condition

- No active infection

- No other currently active malignancy except nonmelanoma skin cancer

- Malignancies for which therapy has been completed and are considered to have ≤
30% chance of risk of relapse are not considered active


- No prior chemotherapy or VEGF inhibitor

- No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in
another experimental drug study except a Genentech-sponsored bevacizumab cancer study

- No major surgical procedure, open biopsy, or significant traumatic injury within the
past 28 days

- No anticipation for major surgical procedure during study treatment

- No fine-needle aspiration or core biopsy within 7 days prior to study entry

- No concurrent full-dose anticoagulation

- No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for this cancer

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response rate by CT scan after 3 courses of induction treatment

Outcome Time Frame:

After 3 cycles of induction treatment

Safety Issue:


Principal Investigator

Sarita Dubey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

April 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



UCSF Comprehensive Cancer CenterSan Francisco, California  94115