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High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without a Biological Inhibitor in Treating Patients with Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Contact Information

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Aarti Rao
(650) 736-0798
akrao@stanford.edu

Recruiting Status: Recruiting

Stanford Recruiting Status: Recruiting

Investigator(s):

Description:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Biological inhibitors like cetuximab may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer. Cetuximab has been approved by the FDA as a treatment for patients with colorectal and head and neck cancer. Cetuximab has not yet been approved as a treatment for patients with lung cancer and is considered experimental in this study. PURPOSE: This randomized phase III trial is studying high-dose radiation therapy given together with chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. It is also studying the effects of adding cetuximab to radiation and chemotherapy. In this study, patients will get either radiation and chemotherapy or radiation, chemotherapy and cetuximab.

Conditions Studied:

Lead Sponsor: Radiation Therapy Oncology Group

Collaborator(s):

Intervention(s):

Phase: Phase 3


Eligibility

Key Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer (NSCLC)
o Stage IIIA or IIIB disease
a. N3 supraclavicular disease or contralateral hilar lymph node involvement (i.e. greater than 1.5 cm on short axis or positive on PET scan) not allowed
o Unresectable or inoperable disease

- No distant metastases

- No Pancoast tumors

- No planned treatment with a maximum dose of >= 66 Gy to the ipsilateral brachial plexus

- Pleural effusion allowed provided effusion is minimal and none of the following conditions are present:
o Cytologically positive pleural effusion detectable by CT scan and chest x-ray (pleuracentesis required to confirm negative cytology of pleural fluid)
o Greater than minimal pleural effusions (minimal effusions not detectable by chest x-ray and too small to tap safely are allowed)
o Exudative pleural effusions, regardless of cytology
o Malignant pleural effusion (T4 incurable disease)

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- ANC >= 1,800 cells/mm^3

- Platelet count >= 100,000 cells/mm^3

- Hemoglobin >= 10.0 g/dL (transfusion or other intervention allowed)

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Bilirubin normal

- AST and ALT < 2.5 times upper limit of normal

- PFTs including FEV1 >= 1.45 L/sec (best value obtained prior to or after use of bronchodilator)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective protection

- No uncontrolled neuropathy >= grade 2

- Patients with post-obstructive pneumonia allowed

- No prior invasive malignancy, except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix, unless the patient has been disease-free for the past 3 years

- No prior severe infusion reaction to a monoclonal antibody

- No weight loss of >= 10% within the past 4 weeks

- No history of allergic reaction to paclitaxel or other taxanes, or to carboplatin

- No severe, active comorbidity, including any of the following:
o Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
o Transmural myocardial infarction within the past 6 months
o Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
o Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or within past 30 days precluding study therapy
o Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
o AIDS

- No significant history of uncontrolled cardiac disease, including any of the following:
o Uncontrolled hypertension
o unstable angina
o Myocardial infarction within the past 6 months
o Uncontrolled congestive heart failure
o Cardiomyopathy with decreased ejection fraction

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior exploratory thoracotomy (if performed)

- Prior systemic chemotherapy allowed, provided it was not given for NSCLC

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior radiotherapy to the region of NSCLC that would result in overlap of radiotherapy fields

- No concurrent WBC growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) given during radiotherapy or prophylactically during consolidation chemotherapy

Key Exclusion Criteria:

Ages Eligible for Study: 18 years to Any Age

Genders Eligible for Study: Male and Female

Healthy Volunteers?: People with the conditions listed in this trial can not participate as controls.

Additional Study Details

Official Title: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND#103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Anticipated start date: 1/7/2008

Study Type: Interventional

Purpose: Treatment

Allocation: Randomized

Masking: Open

Control: none

Assignment: Parallel

Endpoints: Safety/Efficacy

Primary Outcomes:

Secondary Outcomes:

Total Number to be Enrolled: 512

Total Number to be Enrolled at Stanford: 20


More Information

Trial Unique Id: SU-06052008-1193

Secondary ID(s)


Locations & Contacts
Stanford Locations & Contacts

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Aarti Rao
(650) 736-0798
akrao@stanford.edu

Non-Stanford Locations

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated: 8/19/2009

PLEASE NOTE: Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or email referral@medcenter.stanford.edu .

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