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Clinical Trial Title
Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Location and Contact Information
Rebecca and John Moores UCSD Cancer Center
Location and Contact Information
Saint Rose Hospital
Location and Contact Information
Valley Care Medical Center
Location and Contact Information
Bendheim Cancer Center at Greenwich Hospital
Location and Contact Information
CCOP - Christiana Care Health Services
Location and Contact Information
Tunnell Cancer Center at Beebe Medical Center
Location and Contact Information
Sibley Memorial Hospital
Location and Contact Information
Florida Hospital Cancer Institute at Florida Hospital Orlando
Location and Contact Information
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Location and Contact Information
La Grange Memorial Hospital
Location and Contact Information
Louis A. Weiss Memorial Hospital
Location and Contact Information
University of Chicago Cancer Research Center
Location and Contact Information
Fort Wayne Medical Oncology and Hematology
Location and Contact Information
Hematology Oncology Associates of the Quad Cities
Location and Contact Information
Holden Comprehensive Cancer Center at University of Iowa
Location and Contact Information
Iowa Blood and Cancer Care
Location and Contact Information
Mercy Regional Cancer Center at Mercy Medical Center
Location and Contact Information
St. Luke's Hospital
Location and Contact Information
Greenebaum Cancer Center at University of Maryland Medical Center
Location and Contact Information
Union Hospital Cancer Program at Union Hospital
Location and Contact Information
Upper Chesapeake Medical Center
Location and Contact Information
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Location and Contact Information
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Location and Contact Information
Missouri Baptist Cancer Center
Location and Contact Information
Missouri Cancer Associates
Location and Contact Information
Saint Luke's Hospital
Location and Contact Information
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
Location and Contact Information
St. Anthony's Cancer Center
Location and Contact Information
Callahan Cancer Center at Great Plains Regional Medical Center
Location and Contact Information
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Location and Contact Information
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Location and Contact Information
CCOP - Nevada Cancer Research Foundation
Location and Contact Information
University Medical Center of Southern Nevada
Location and Contact Information
Elliot Regional Cancer Center at Elliot Hospital
Location and Contact Information
Lakes Region General Hospital
Location and Contact Information
New Hampshire Oncology - Hematology, PA - Hooksett
Location and Contact Information
Cancer Institute of New Jersey at Cooper - Voorhees
Location and Contact Information
St. Joseph's Hospital and Medical Center
Location and Contact Information
CCOP - Hematology-Oncology Associates of Central New York
Location and Contact Information
Charles R. Wood Cancer Center at Glens Falls Hospital
Location and Contact Information
Mount Sinai Medical Center
Location and Contact Information
SUNY Upstate Medical University Hospital
Location and Contact Information
Veterans Affairs Medical Center - Syracuse
Location and Contact Information
Duke Comprehensive Cancer Center
Location and Contact Information
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Location and Contact Information
Kinston Medical Specialists
Location and Contact Information
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Location and Contact Information
Mission Hospitals - Memorial Campus
Location and Contact Information
Pardee Memorial Hospital
Location and Contact Information
Wayne Memorial Hospital, Incorporated
Location and Contact Information
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Location and Contact Information
Cancer Care Associates - Mercy Campus
Location and Contact Information
Oklahoma University Cancer Institute
Location and Contact Information
Miriam Hospital
Location and Contact Information
Rhode Island Hospital Comprehensive Cancer Center
Location and Contact Information
McLeod Regional Medical Center
Location and Contact Information
Roper St. Francis Cancer Center at Roper Hospital
Location and Contact Information
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Location and Contact Information
Fletcher Allen Health Care - University Health Center Campus
Location and Contact Information
Mountainview Medical
Location and Contact Information
Danville Regional Medical Center
Location and Contact Information
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Location and Contact Information
Southwest Virginia Regional Cancer Center at Wellmonth Health
Location and Contact Information
Virginia Commonwealth University Massey Cancer Center
Location and Contact Information
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Status Active, not recruiting
Sponsors
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Purpose
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as 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 cetuximab, 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. Cetuximab may also make tumor cells more
sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation
therapy together with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and
carboplatin together with radiation therapy with or without cetuximab works in treating
patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Study Design: Treatment, Randomized
Eligibility
Genders Eligible for Study: Both
Ages eligible for study: 18 Years to N/A
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
including any of the following subtypes:
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell carcinoma)
- Large cell anaplastic carcinoma (including giant cell and clear cell carcinoma)
- Stage IIIA OR selected stage IIIB disease*
- Any T, N2-3, M0 disease
- T3, N1-3, M0 disease allowed provided disease is unresectable
- T4, any N, M0 disease allowed provided T4 status cannot be determined due to
malignant effusion
- No T3, N0, M0 disease NOTE: *If the largest mediastinal lymph node is < 2 cm in
diameter by CT scan, a biopsy confirmation of mediastinal nodal involvement is
required
- Unresectable disease
- Contralateral mediastinal disease (N3) allowed provided all gross disease can be
encompassed within the radiation field in accordance with the homogeneity criteria
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan
- The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated area
- No exudative, bloody, or cytologically positive malignant effusion
- Transudate, cytologically negative, non-bloody pleural effusion allowed provided
the tumor can be encompassed within a reasonable field of radiotherapy
- Pleural effusion detectable by chest CT scan but not by chest x-ray that is too
small to tap allowed
- New pleural effusion appearing after thoracotomy or other invasive thoracic
procedure allowed
- No atelectasis of the entire lung
- No direct invasion of the vertebral body
- No scalene, supraclavicular, or contralateral hilar node involvement
- No distant metastases (M1) by fludeoxyglucose F18 positron emission tomography
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT < 3 times ULN
- Alkaline phosphatase < 3 times ULN
Renal
- Creatinine clearance ≥ 45 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight loss ≤ 10% within the past 3 months
- No other active* malignancy except nonmelanoma skin cancer
- No ongoing or active infection
- No psychiatric illness
- No other uncontrolled illness
- No history of hypersensitivity to carboplatin, pemetrexed disodium, or a monoclonal
antibody NOTE: *Malignancy is not considered active if the patient has completed
treatment and has < 30% risk of relapse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during
thoracic radiotherapy or as prophylaxis for myelosuppression
Chemotherapy
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy except megestrol for appetite stimulation or
dexamethasone to prevent rash from pemetrexed disodium
Radiotherapy
- No prior radiotherapy to the chest
- No concurrent palliative radiotherapy
- No concurrent intensity modulated radiotherapy
Surgery
- See Disease Characteristics
- At least 2 weeks since prior formal exploratory thoracotomy
Other
- No prior therapy that directly targets the epidermal growth factor receptor pathway
- No concurrent combination antiretroviral therapy for HIV-positive patients
More Information
Study ID numbers:
CDR0000434616
CALGB-30407
ClinicalTrials Identifier - NCT00117962
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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