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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00492206
Other study ID # UPCI 05-106
Secondary ID
Status Completed
Phase Phase 2
First received June 26, 2007
Last updated January 16, 2013
Start date June 2006
Est. completion date February 2012

Study information

Verified date January 2013
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
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 -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 Sylvester Comprehensive Cancer Center, University of Miami Miami Florida
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 Mt. Pleasant Pennsylvania
United States UPMC Cancer Center -Jameson New Castle Pennsylvania
United States UPMC Cancer Center -New Castle New Castle Pennsylvania
United States Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center Pittsburgh Pennsylvania
United States UPMC Cancer Center -Delafield Rd. Pittsburgh Pennsylvania
United States UPMC Cancer Center -Drake Pittsburgh Pennsylvania
United States UPMC Cancer Center -Passavant Pittsburgh Pennsylvania
United States UPMC Cancer Center -St. Clair Pittsburgh Pennsylvania
United States UPMC Cancer Center -St. Margaret Pittsburgh Pennsylvania
United States UPMC Cancer Center -UPMC Shadyside Pittsburgh Pennsylvania
United States UPMC Presbyterian -Radiation Oncology Pittsburgh Pennsylvania
United States UPMC Cancer Center -UPMC Northwest Seneca Pennsylvania
United States UPMC Cancer Center -Teramana Cancer Center Steubenville Ohio
United States UPMC Cancer Center -Robert Eberly Pavilion Uniontown Pennsylvania
United States UPMC Cancer Center -Uniontown Uniontown Pennsylvania
United States UPMC Cancer Center -Washington Washington Pennsylvania
United States UPMC Cancer Center -Wexford Wexford Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the response rate with cetuximab and concurrent thoracic radiotherapy for patients with locally advanced NSCLC approx. 5 years Yes
Secondary To determine the progression free survival 5 years No
Secondary To evaluate the safety of the treatment regimen approx. 6-8 months Yes
Secondary To conduct correlative science studies on the baseline tumor tissue to evaluate for EGFR mutations and Akt, p-Akt, and MAPKinase approx. 5 years No
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