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)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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) |
- Mediastinal nodal clearance after completion of induction chemoradiotherapy with or without cetuximab [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Patterns of first failure [ Designated as safety issue: No ]
- Acute and late adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Surgical morbidities in patients with resectable disease at reassessment [ 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) [ Designated as safety issue: No ]
- Prognostic value of plasma osteopontin and microRNA for overall survival [ Designated as safety issue: No ]
- Ability of FDG-PET/PT scan data to predict outcome [ Designated as safety issue: No ]
- Response rate [ 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 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 |
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
- 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)
- ALT and 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
- 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
Hide Study 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 | |
| Study Chair: | Martin J. Edelman, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00979212 History of Changes |
| Other Study ID Numbers: | CDR0000654690, RTOG-0839 |
| Study First Received: | September 16, 2009 |
| Last Updated: | September 18, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 May 23, 2013