Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherRTOG-0839
CDR0000654690, NCI-2011-01970, NCT00979212

Trial Description

Summary

RATIONALE: 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. Radiation therapy 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. (cetuximab closed as of 05/14/10)

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. (cetuximab closed as of 05/14/10)

Further Study Information

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. (cetuximab closed as of 05/14/10)

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. (cetuximab closed as of 05/14/10) 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.

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
  • Pleural effusion allowed provided one of the following criteria is met:
  • If pleural fluid is present either before or after pre-study mediastinoscopy or exploratory thoracotomy, a thoracentesis must be performed to document that the pleural effusion is cytologically negative
  • If pleural fluid is present on CT scan, but is deemed too small to tap safely under either CT scan or ultrasound guidance, a thoracoscopy should be done, if feasible, to document the absence of pleural metastases and to document that the pleural effusion is cytologically negative
  • 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 or nursing
  • 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:
  • Uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy [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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
Martin J. Edelman, MD, Principal Investigator

Trial Sites

U.S.A.

California
Palo Alto

Stanford Cancer Center

Billy W Loo
Ph: 650-498-7061
Email: ccto-office@stanford.edu

Colorado
Colorado Springs

Penrose Cancer Center at Penrose Hospital

Keren Sturtz
Ph: 888-785-6789

Georgia
Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Aaron W Pederson
Ph: 912-350-8568

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

John A Pablo
Ph: 800-622-6877

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Samir Narayan
Ph: 734-712-4673

Illinois
Chicago

Saint Joseph Hospital

Nicholas S Galanopoulos
Ph: 773-665-3109

Warrenville

Central Dupage Cancer Center

Nasiruddin Mohammed
Ph: 630-352-5300

Indiana
Goshen

Center for Cancer Care at Goshen General Hospital

James A. Wheeler
Ph: 574-535-2858

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Ronald McGarry
Ph: 859-257-3379

Louisville

University of Louisville School of Medicine

Neal E Dunlap
Ph: 866-530-5516

Louisiana
New Orleans

Ochsner Cancer Institute at Ochsner Clinic Foundation

Mini J Elnaggar
Ph: 888-562-4763

Maryland
Baltimore

Greenebaum Cancer Center at University of Maryland Medical Center

Steven Feigenberg
Ph: 800-888-8823

St. Agnes Hospital Cancer Center

Richard S. Hudes
Ph: 410-368-2910

Bel Air

Upper Chesapeake Medical Center

Steven Feigenberg
Ph: 800-888-8823

Massachusetts
Boston

Boston University Cancer Research Center

Gregory A Russo
Ph: 617-638-8265

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Samir Narayan
Ph: 734-712-4673

Minnesota
Coon Rapids

Mercy and Unity Cancer Center at Mercy Hospital

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Edina

Fairview Southdale Hospital

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Minneapolis

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Mississippi
Jackson

University of Mississippi Cancer Clinic

Shankar P Giri
Ph: 601-815-6700

Nebraska
Omaha

Methodist Estabrook Cancer Center

Tien-Shew W Huang
Ph: 402-354-5144

New York
New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Simon K Cheng
Ph: 212-305-8615

Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Yuhchyau Chen
Ph: 585-275-5830

Ohio
Akron

Summa Center for Cancer Care at Akron City Hospital

Charles A Kunos
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Charles A Kunos
Ph: 330-375-6101

Cleveland

Cleveland Clinic Taussig Cancer Center

Gregory Videtic
Ph: 866-223-8100

Strongsville

Cleveland Clinic Foundation - Strongsville

Gregory Videtic
Ph: 866-223-8100

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Terence S. Herman
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Pennsylvania
Bryn Mawr

Bryn Mawr Hospital

Albert S DeNittis
Ph: 866-225-5654

Danville

Geisinger Cancer Institute at Geisinger Health

Thomas J Gergel
Ph: 570-271-5251

Gettysburg

Adams Cancer Center

Amit B. Shah
Ph: 877-441-7957

Hanover

Cherry Tree Cancer Center

Amit B. Shah
Ph: 877-441-7957

Paoli

Cancer Center of Paoli Memorial Hospital

Albert S DeNittis
Ph: 866-225-5654

Philadelphia

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Nathaniel R Evans
Ph: 215-955-6084

Pittsburgh

Allegheny Cancer Center at Allegheny General Hospital

Athanasios Colonias
Ph: 877-284-2000

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Albert Yuen
Ph: 610-988-9323

Wexford

Allegheny Health Network

Athanasios Colonias
Ph: 877-284-2000

Wynnewood

Lankenau Cancer Center at Lankenau Hospital

Albert S DeNittis
Ph: 866-225-5654

York

WellSpan Health

Amit B. Shah
Ph: 877-441-7957

Utah
Salt Lake City

Huntsman Cancer Institute at University of Utah

Shamus R Carr
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Wisconsin
Menomonee Falls

Community Memorial Hospital Cancer Care Center

Elizabeth M. Gore
Ph: 414-805-4380

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Elizabeth M. Gore
Ph: 414-805-4380

Veterans Affairs Medical Center - Milwaukee

Elizabeth M. Gore
Ph: 414-805-4380

West Bend

Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital

Elizabeth M. Gore
Ph: 414-805-4380

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00979212
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.