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Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer



- Evaluate reduction in toxicity, in terms of pulmonary hemorrhage, in patients with
recurrent, unresectable or stage IIIB or IV squamous non-small cell lung cancer treated
with radiotherapy followed by paclitaxel, carboplatin, and bevacizumab.


- Determine the overall and progression-free survival of patients treated with this

OUTLINE: Patients undergo radiotherapy to the primary tumor, clinically involved lymph
nodes, and any other disease-causing symptoms or bronchial compression once daily, 5 days a
week, for 2 weeks in weeks 1 and 2. Beginning in week 4, patients receive paclitaxel IV over
3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Treatment with paclitaxel, carboplatin, and bevacizumab repeats every 3 weeks for 4 courses
in the absence of unacceptable toxicity. Patients achieving complete response, partial
response, or stable disease after 4 courses receive bevacizumab alone as above in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Predominantly squamous cell histology

- Cytologic or histologic elements can be established on metastatic tumor
aspirates or biopsy

- Advanced disease, meeting 1 of the following staging criteria:

- Stage IIIB disease with malignant pleural effusion

- Stage IV disease

- Recurrent, unresectable disease

- Measurable or nonmeasurable disease

- No extrathoracic only disease

- No known CNS metastases by head CT scan with contrast or MRI


- ECOG performance status 0-1

- Platelet count > 100,000/mm^3

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

- Bilirubin < 1.5 mg/dL

- Transaminases < 5 times upper limit of normal (ULN)

- Creatinine clearance ≥ 45 mL/min

- Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis

- INR < 1.5 ULN

- PTT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients use effective contraception

- No serious nonhealing wound, ulcer, or bone fracture

- No ongoing or active infection

- No ongoing fever

- No myocardial infarction within the past 6 months

- No stroke within the past 6 months

- No history of hypertension unless well-controlled (i.e., blood pressure < 150/100
mmHg on a stable regimen of antihypertensive therapy)

- No New York Heart Association grade III or IV congestive heart failure

- No serious cardiac arrhythmia requiring medication

- No unstable angina pectoris

- No peripheral vascular disease ≥ grade 2

- No other clinically significant cardiovascular disease

- No abdominal fistula

- No gastrointestinal perforation

- No intra-abdominal abscess within the past 6 months

- No psychiatric illness or social situation that would preclude study compliance

- No other malignancy curatively treated within the past 5 years

- No history of thrombotic or hemorrhagic disorders

- No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months

- No bleeding requiring intervention or ≥ grade 2


- Recovered from prior therapy

- No prior systemic chemotherapy for metastatic NSCLC

- More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage

- More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy

- More than 28 days since prior and no concurrent major surgery

- More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy

- More than 4 weeks since prior and no concurrent participation in another experimental
drug study

- No concurrent therapeutic anticoagulation

- Concurrent prophylactic anticoagulation of venous access device allowed

- No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal
anti-inflammatory drugs known to inhibit platelet function

- No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in toxicity measured by pulmonary hemorrhage rate

Safety Issue:


Principal Investigator

Jyoti D. Patel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 05L1



Start Date:

May 2006

Completion Date:

November 2007

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Evanston Northwestern Healthcare - Evanston Hospital Evanston, Illinois  60201-1781
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294