Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00334763
• Other study ID #: NU 05L1
• Secondary ID: NU-05L1NU-1362-0
• Status: Terminated
• Phase: Phase 2
• First received: June 7, 2006
• Last updated: July 9, 2012
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage III or stage IV non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• 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.

Secondary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: November 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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 IB-IIIA) NSCLC

• 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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• carboplatin

• chemoprotection

• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in toxicity measured by pulmonary hemorrhage rate			Yes
Secondary	Overall survival by Kaplan-Meier			No
Secondary	Response rate			No
Secondary	Toxicity			Yes