Trial record 1 of 1 for:    rtog and 0839
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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)

This study is currently recruiting participants.
Verified February 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00979212
First received: September 16, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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)


Condition Intervention Phase
Lung Cancer
Biological: panitumumab
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy +/- Cetuximab in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab. [ Time Frame: At the time of protocol surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Time from randomization until date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 10 months. ] [ Designated as safety issue: No ]
  • Patterns of first failure [ Time Frame: Time from randomization until first failure. Analysis occurs after all patients have been potentially followed for 10 months. ] [ Designated as safety issue: No ]
  • Acute and late adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 [ Time Frame: From start of treatment until end of follow-up. ] [ Designated as safety issue: Yes ]
  • Surgical morbidities in patients with resectable disease at reassessment [ Time Frame: From date of surgery until 30 days following surgery. ] [ Designated as safety issue: No ]
  • Correlation between pre- and post-treatment biomarkers (including EGFR and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival) [ Time Frame: Time from randomization until date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 10 months. ] [ Designated as safety issue: No ]
  • Prognostic value of plasma osteopontin and microRNA for overall survival [ Time Frame: Time from randomization until date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 10 months. ] [ Designated as safety issue: No ]
  • Ability of FDG-PET/PT scan data to predict outcome [ Time Frame: Time from randomization until date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 10 months. ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Time from randomization until date of best response to protocol treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 97
Study Start Date: February 2011
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Experimental: 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)
Biological: panitumumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV

Detailed 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. (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979212

  Hide Study Locations
Locations
United States, California
Mercy Cancer Center at Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Contact: Christopher Jones, MD    916-646-6600      
Radiological Associates of Sacramento Medical Group, Incorporated Recruiting
Sacramento, California, United States, 95815
Contact: Christopher Jones, MD    916-646-6600      
United States, Colorado
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
United States, Louisiana
CCOP - Ochsner Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mini J. Elnaggar    504-842-3910      
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
St. Agnes Hospital Cancer Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard S. Hudes, MD    410-368-2965      
Cancer Institute at St. Joseph Medical Center Recruiting
Towson, Maryland, United States, 21204
Contact: Jason R. Citron    410-337-1000      
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
United States, Minnesota
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clifford G Robinson    314-747-7222      
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang    402-354-5890      
United States, New York
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Silvia C. Formenti    212-263-6485      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5345      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kevin P. Redmond, MD    513-584-9089      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles E. Stewart    918-494-2273      
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Clinical Trials Office - Bryn Mawr Hospital    610-645-2680      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amit B. Shah    717-741-8180      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Amit B. Shah    717-741-8180      
Cancer Center of Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301-1792
Contact: Clinical Trials Office - Cancer Center of Paoli Memorial Hospi    610-648-1637      
Albert Einstein Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Kenneth L. Zeitzer, MD    215-456-6280      
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
Lankenau Cancer Center at Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman, MD    610-645-2000      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amit B. Shah    717-741-8180      
United States, Wisconsin
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Veterans Affairs Medical Center - Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD    414-805-4369      
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Martin J. Edelman, MD University of New Mexico
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00979212     History of Changes
Other Study ID Numbers: RTOG-0839, CDR0000654690
Study First Received: September 16, 2009
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 22, 2014