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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab.

Outcome Time Frame:

At the time of protocol surgery.

Safety Issue:

No

Principal Investigator

Martin J. Edelman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

RTOG-0839

NCT ID:

NCT00979212

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Fairview Southdale HospitalEdina, Minnesota  55435
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Boston University Cancer Research CenterBoston, Massachusetts  02118
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Cancer Institute at St. Joseph Medical CenterTowson, Maryland  21204
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331