Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC

NCT00492206 | Completed Phase 2 Results DMC

• 2 other identifiers: 05-106NCT00492206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Non Small Cell Lung Cancer; NSCLC; EGFR Inhibitor; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 36 months

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Up to 36 months

• Best Overall Response Rate (ORR) (Number of Participants)

  Up to 12 weeks after treatment initiation

• EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase

  approx. 5 years

Study Arms (1)

Cetuximab

EXPERIMENTAL

Cetuximab 400 mg/m2 IV week 0 only External beam radiation weeks 1 - 7 Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7 Cetuximab 250 mg/m2 IV weekly weeks 8 - 26 Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles

Drug: Cetuximab

Interventions

Cetuximab DRUG

The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.

Also known as: Erbitux, C225

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bristol-Myers Squibb: collaborator

Study Sites (31)

Sylvester Comprehensive Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, 21231, United States

Location

UPMC Cancer Center -Teramana Cancer Center

Steubenville, Ohio, 43952, United States

Location

UPMC Cancer Center -Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC Cancer Center - Clairton

Clairton, Pennsylvania, 15025, United States

Location

UPMC Cancer Center - Oakbrook Commons

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Cancer Center -Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UPMC Cancer Center -Indiana

Indiana, Pennsylvania, 15701, United States

Location

UPMC Cancer Center -John P. Murtha Pavilion

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Cancer Center -McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Cancer Center -Haymaker Rd.

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Cancer Center -Mosside Blvd.

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Cancer Center -Sewickley Medical Center

Moon Township, Pennsylvania, 15108, United States

Location

UPMC Cancer Center -Mt. Pleasant

Mount Pleasant, Pennsylvania, 15666, United States

Location

UPMC Cancer Center -Jameson

New Castle, Pennsylvania, 16105, United States

Location

UPMC Cancer Center -New Castle

New Castle, Pennsylvania, 16105, United States

Location

UPMC Presbyterian -Radiation Oncology

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Center -Delafield Rd.

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Cancer Center -St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Cancer Center -UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Cancer Center -Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC Cancer Center -Drake

Pittsburgh, Pennsylvania, 15241, United States

Location

UPMC Cancer Center -St. Clair

Pittsburgh, Pennsylvania, 15243, United States

Location

UPMC Cancer Center -UPMC Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC Cancer Center -Robert Eberly Pavilion

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Cancer Center -Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Cancer Center -Washington

Washington, Pennsylvania, 15301, United States

Location

UPMC Cancer Center -Wexford

Wexford, Pennsylvania, 15090, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Ahmad Tarhini, MD
• Organization: University of Pittsburgh Cancer Institute

tarhiniaa@upmc.edu

412-648-6507

Study Officials

• Athanassios Argiris, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Translational Science

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 1, 2017
• Results First Posted: February 1, 2017

Record last verified: 2016-12

Locations

US (31)