Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00492206
First received: June 26, 2007
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To evaluate the response rate with cetuximab and concurrent thoracic radiotherapy for patients with locally advanced NSCLC [ Time Frame: approx. 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate the safety of the treatment regimen [ Time Frame: approx. 6-8 months ] [ Designated as safety issue: Yes ]
  • To conduct correlative science studies on the baseline tumor tissue to evaluate for EGFR mutations and Akt, p-Akt, and MAPKinase [ Time Frame: approx. 5 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab

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
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.
Other Name: Erbitux, C225

Detailed Description:

This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492206

Locations
United States, Florida
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21231
United States, Ohio
UPMC Cancer Center -Teramana Cancer Center
Steubenville, Ohio, United States, 43952
United States, Pennsylvania
UPMC Cancer Center -Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, United States, 15025
UPMC Cancer Center -Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
UPMC Cancer Center - Oakbrook Commons
Greensburg, Pennsylvania, United States, 15601
Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
UPMC Cancer Center -Indiana
Indiana, Pennsylvania, United States, 15701
UPMC Cancer Center -John P. Murtha Pavilion
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center -McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC Cancer Center -Mosside Blvd.
Monroeville, Pennsylvania, United States, 15146
UPMC Cancer Center -Haymaker Rd.
Monroeville, Pennsylvania, United States, 15146
UPMC Cancer Center -Sewickley Medical Center
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center -Mt. Pleasant
Mt. Pleasant, Pennsylvania, United States, 15666
UPMC Cancer Center -New Castle
New Castle, Pennsylvania, United States, 16105
UPMC Cancer Center -Jameson
New Castle, Pennsylvania, United States, 16105
Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center -Delafield Rd.
Pittsburgh, Pennsylvania, United States, 15215
UPMC Presbyterian -Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center -Drake
Pittsburgh, Pennsylvania, United States, 15241
UPMC Cancer Center -Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Center -St. Clair
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center -UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center -St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC Cancer Center -UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Cancer Center -Robert Eberly Pavilion
Uniontown, Pennsylvania, United States, 15401
UPMC Cancer Center -Uniontown
Uniontown, Pennsylvania, United States, 15401
UPMC Cancer Center -Washington
Washington, Pennsylvania, United States, 15301
UPMC Cancer Center -Wexford
Wexford, Pennsylvania, United States, 15090
Sponsors and Collaborators
University of Pittsburgh
Bristol-Myers Squibb
Investigators
Principal Investigator: Athanassios Argiris, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00492206     History of Changes
Other Study ID Numbers: UPCI 05-106
Study First Received: June 26, 2007
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Non Small Cell Lung Cancer
NSCLC
EGFR Inhibitor
Radiation Therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014