Lung Cancer Clinical Trial

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy (CT), 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. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer.

Secondary

Assess overall survival of these patients.
Evaluate patterns of first failure in these patients.
Determine the acute and late adverse events associated with these regimens.
Assess surgical morbidities in patients with resectable disease at reassessment.
Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
Assess the ability of FDG-PET/CT scan re-staging to predict outcome.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
In both arms, patients with resectable disease and no disease progression may proceed to surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after completion of induction therapy. After surgery, patients proceed to consolidation therapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:

Adenocarcinoma
Adenosquamous
Large cell carcinoma
Squamous cell carcinoma
Non-lobar and non-diffuse bronchoalveolar cell carcinoma
NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration

Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)

N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm

N2 status must be pathologically confirmed to be positive by one of the following methods*:

Mediastinoscopy
Mediastinotomy (Chamberlain procedure)
Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
Thoracotomy
Video-assisted thoracoscopy
Transbronchial needle biopsy by Wang technique (TBNA)
Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status

Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:

Tumor is left sided
Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
Nodes visible in the anterior/posterior (level 5) region on CT scan
Distinct primary tumor separate from nodes visible on CT scan
Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative

Measurable disease as determined by contrast-enhanced CT scan

Primary lung tumor distinct from mediastinal lymph nodes

If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):

When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
Exudative pleural effusions are excluded, regardless of cytology;
Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible.
No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
No distant metastases

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Absolute neutrophil count (ANC) ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Creatinine clearance ≥ 60 mL/min
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Serum albumin > 3.0 g/dL
Serum magnesium normal (supplementation allowed)
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of treatment
Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
Diffusion capacity ≥ 50% predicted
No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix

No severe, active co-morbidity, including any of the following:

Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (<50%)
Acute bacterial or fungal infection requiring IV antibiotics
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
AIDS or known HIV positivity
No unintentional weight loss ≥ 5% of body weight within the past 6 months
No prior severe infusion reaction to a monoclonal antibody
No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer

Prior chemotherapy for a different cancer allowed
No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
No prior therapy that specifically and directly targets the EGFR pathway

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

71

Study ID:

NCT00979212

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 31 Locations for this study

See Locations Near You

Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael California, 95608, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento California, 95815, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
St. Agnes Hospital Cancer Center
Baltimore Maryland, 21229, United States
Cancer Institute at St. Joseph Medical Center
Towson Maryland, 21204, United States
Boston University Cancer Research Center
Boston Massachusetts, 02118, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
NYU Cancer Institute at New York University Medical Center
New York New York, 10016, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Adams Cancer Center
Gettysburg Pennsylvania, 17325, United States
Cherry Tree Cancer Center
Hanover Pennsylvania, 17331, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
York Cancer Center at Apple Hill Medical Center
York Pennsylvania, 17405, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

71

Study ID:

NCT00979212

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

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