Lung Cancer Clinical Trial
Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Summary
This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.
Full Description
PRIMARY OBJECTIVES:
I. Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin, etoposide, and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab, in terms of grade 4 or 5 hemorrhage, in patients with newly diagnosed, unresectable, stage III non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. Determine progression-free and overall survival of patients treated with these regimens.
II. Determine response (confirmed, unconfirmed, partial, and complete) in patients with measurable disease treated with these regimens.
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to risk (high* vs low).
NOTE: *High-risk stratum closed to accrual as of 2/20/09.
INDUCTION THERAPY: Patients in each stratum are assigned to 1 of 3 sequential treatment groups.
GROUP 1: Patients receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
GROUP 2: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
GROUP 3: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.
CONSOLIDATION CHEMOTHERAPY: Beginning 3-6 weeks after completion of induction therapy, all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 4 years.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC)
Newly diagnosed disease
Unresectable disease
No more than 1 parenchymal lesions on same or opposite sides of the lungs
Meets 1 of the following stage criteria:
Stage IIIA (N2) disease meeting the following criteria:
N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection
N2 status must be documented by ≥ 1 of the following methods:
Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method
Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan
Nodes > 3 cm on CT scan
Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan
Stage IIIB disease meeting ≥ 1 of the following criteria:
Histologically or radiographically confirmed positive N3 nodes*, documented by ≥ 1 of the following methods:
FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes
Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
Contralateral mediastinal nodes > 3 cm on CT scan
Node positivity by FDG-PET scan
Right-sided primary with paralyzed left true vocal cord
T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods:
Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy
T4 involvement of the trachea or carina by direct bronchoscopic visualization
T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound
T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space**
Meets 1 of the following risk criteria:
Low risk disease, meeting the following criteria:
Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma
If mixed histology, the squamous cell carcinoma component must be < 50%
Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required)
No primary tumor with cavitation and/or tumor within 1 cm of a major vessel
No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days
High-risk* disease, meeting ≥ 1 of the following criteria:
Squamous cell NSCLC
If mixed histology, the squamous cell component must be ≥ 50%
Tumor with any histology that has cavitation or is located within 1 cm of a major vessel
No aortic involvement
Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days
Measurable or nonmeasurable disease by CT scan or MRI
Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
No pleural effusion except for small pleural effusion visible on CT scan or MRI alone
No pericardial effusions
No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report
Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol)
No brain metastases by CT scan or MRI
No evidence of cavitation
Creatinine normal
Creatinine clearance ≥ 50 mL/min
FEV_1 ≥ 2.0 liters OR predicted FEV_1 of the contralateral lung > 800 mL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein < 1,000 mg by 24-hour urine collection
INR < 1.5
Zubrod performance status 0-1
No sensory neuropathy > grade 1
No cerebrovascular accident within the past 6 months
No myocardial infarction or unstable angina within the past 6 months
No uncontrolled hypertension
No New York Heart Association class II-IV congestive heart failure
No serious cardiac arrhythmia requiring medication
No clinically significant peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No pathologic condition other than lung cancer that carries a high risk of bleeding
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
No serious, nonhealing wound, ulcer, or bone fracture
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years
Not pregnant or nursing
No nursing during and for ≥ 6 months after the last dose of bevacizumab
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab
Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy
No prior surgical resection
Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor
No prior chemotherapy or radiotherapy for lung cancer
No prior radiotherapy to the neck or thorax
At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered
More than 7 days since prior FNA, CNB, or mediastinoscopy
No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents
No other concurrent investigational drugs
No concurrent major surgical procedures
No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin)
Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line
No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes
No concurrent intensity-modulated radiotherapy
No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy
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There are 57 Locations for this study
Mobile Alabama, 36608, United States
Jonesboro Arkansas, 72401, United States
Little Rock Arkansas, 72205, United States
Rogers Arkansas, 72758, United States
Los Angeles California, 90033, United States
Marysville California, 95901, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Santa Rosa California, 95405, United States
Truckee California, 96161, United States
Vacaville California, 95687, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80204, United States
Denver Colorado, 80217, United States
Edwards Colorado, 81632, United States
Glenwood Springs Colorado, 81601, United States
Montrose Colorado, 81401, United States
Leesburg Florida, 34788, United States
Savannah Georgia, 31405, United States
Maywood Illinois, 60153, United States
Naperville Illinois, 60540, United States
Hays Kansas, 67601, United States
Hutchinson Kansas, 67502, United States
Kansas City Kansas, 66160, United States
Olathe Kansas, 66061, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66606, United States
Shreveport Louisiana, 71103, United States
Shreveport Louisiana, 71105, United States
Brighton Massachusetts, 02135, United States
Detroit Michigan, 48201, United States
Mount Clemens Michigan, 48043, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64128, United States
Billings Montana, 59102, United States
Great Falls Montana, 59405, United States
Elmira New York, 14905, United States
Rochester New York, 14620, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27104, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29401, United States
Kingsport Tennessee, 37660, United States
Memphis Tennessee, 38163, United States
Amarillo Texas, 79106, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Danville Virginia, 24541, United States
Norton Virginia, 24273, United States
Auburn Washington, 98001, United States
Centralia Washington, 98531, United States
Federal Way Washington, 98003, United States
Lakewood Washington, 98499, United States
Olympia Washington, 98506, United States
Puyallup Washington, 98372, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
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