Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC

Completed · Phase 2

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.

Key facts

Study ID

NCT00492206

Run by

University of Pittsburgh

People needed

40

Starts

2006-06-01

Expected to finish

2012-02-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer
• Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion
• Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
• Age >18 years. Lung cancer is extremely rare in children.
• ECOG performance status 0-1 (Karnofsky >70%; see Appendix A).
• If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies.
• Patients must have normal organ and marrow function as defined below:
• leukocytes >3,000/μL
• absolute neutrophil count >1,500/μL
• platelets >100,000/μL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
• creatinine within normal institutional limits OR
• creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• Willingness to sign an approved informed consent.

You may not qualify if…

• Patients should not have received prior chest radiation therapy.
• Patients with a history of pulmonary fibrosis are excluded from study.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.
• History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
• Prior therapy with known specific inhibitors of the EGFR.
• History of severe allergic reaction to prior therapy with monoclonal antibodies
• Peripheral neuropathy of more than grade 1 in severity
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study.
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
• Active hepatitis.
• History of pulmonary fibrosis.

Where it is running

• Sylvester Comprehensive Cancer Center, University of Miami — Miami, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
• UPMC Cancer Center -Teramana Cancer Center — Steubenville, Ohio, United States
• UPMC Cancer Center -Beaver — Beaver, Pennsylvania, United States
• UPMC Cancer Center - Clairton — Clairton, Pennsylvania, United States
• UPMC Cancer Center - Oakbrook Commons — Greensburg, Pennsylvania, United States
• UPMC Cancer Center -Arnold Palmer Pavilion — Greensburg, Pennsylvania, United States
• Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• UPMC Cancer Center -Indiana — Indiana, Pennsylvania, United States
• UPMC Cancer Center -John P. Murtha Pavilion — Johnstown, Pennsylvania, United States
• UPMC Cancer Center -McKeesport — McKeesport, Pennsylvania, United States
• UPMC Cancer Center -Haymaker Rd. — Monroeville, Pennsylvania, United States
• UPMC Cancer Center -Mosside Blvd. — Monroeville, Pennsylvania, United States
• UPMC Cancer Center -Sewickley Medical Center — Moon Township, Pennsylvania, United States
• UPMC Cancer Center -Mt. Pleasant — Mount Pleasant, Pennsylvania, United States
• UPMC Cancer Center -Jameson — New Castle, Pennsylvania, United States
• UPMC Cancer Center -New Castle — New Castle, Pennsylvania, United States
• UPMC Presbyterian -Radiation Oncology — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Center -Delafield Rd. — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Center -St. Margaret — Pittsburgh, Pennsylvania, United States
• Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Center -UPMC Shadyside — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Center -Passavant — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Center -Drake — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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