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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the response rate with cetuximab and concurrent thoracic radiotherapy for patients with locally advanced NSCLC

Outcome Time Frame:

approx. 5 years

Safety Issue:

Yes

Principal Investigator

Athanassios Argiris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

UPCI 05-106

NCT ID:

NCT00492206

Start Date:

June 2006

Completion Date:

February 2012

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • Non Small Cell Lung Cancer
  • NSCLC
  • EGFR Inhibitor
  • Radiation Therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Emory Winship Cancer InstituteAtlanta, Georgia  30322
UPMC Cancer Center - ClairtonClairton, Pennsylvania  15025
Sylvester Comprehensive Cancer Center, University of MiamiMiami, Florida  33136
Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, Maryland  21231
UPMC Cancer Center -Teramana Cancer CenterSteubenville, Ohio  43952
UPMC Cancer Center -BeaverBeaver, Pennsylvania  15009
UPMC Cancer Center -Arnold Palmer PavilionGreensburg, Pennsylvania  15601
UPMC Cancer Center - Oakbrook CommonsGreensburg, Pennsylvania  15601
Penn State Cancer Institute, Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
UPMC Cancer Center -IndianaIndiana, Pennsylvania  15701
UPMC Cancer Center -John P. Murtha PavilionJohnstown, Pennsylvania  15901
UPMC Cancer Center -McKeesportMcKeesport, Pennsylvania  15132
UPMC Cancer Center -Mosside Blvd.Monroeville, Pennsylvania  15146
UPMC Cancer Center -Haymaker Rd.Monroeville, Pennsylvania  15146
UPMC Cancer Center -Sewickley Medical CenterMoon Township, Pennsylvania  15108
UPMC Cancer Center -Mt. PleasantMt. Pleasant, Pennsylvania  15666
UPMC Cancer Center -New CastleNew Castle, Pennsylvania  16105
UPMC Cancer Center -JamesonNew Castle, Pennsylvania  16105
Universtity of Pittsburgh Cancer Institute -Hillman Cancer CenterPittsburgh, Pennsylvania  15232
UPMC Cancer Center -PassavantPittsburgh, Pennsylvania  15237
UPMC Presbyterian -Radiation OncologyPittsburgh, Pennsylvania  15213
UPMC Cancer Center -DrakePittsburgh, Pennsylvania  15241
UPMC Cancer Center -Delafield Rd.Pittsburgh, Pennsylvania  15215
UPMC Cancer Center -St. ClairPittsburgh, Pennsylvania  15243
UPMC Cancer Center -UPMC ShadysidePittsburgh, Pennsylvania  15232
UPMC Cancer Center -St. MargaretPittsburgh, Pennsylvania  15215
UPMC Cancer Center -UPMC NorthwestSeneca, Pennsylvania  16346
UPMC Cancer Center -Robert Eberly PavilionUniontown, Pennsylvania  15401
UPMC Cancer Center -UniontownUniontown, Pennsylvania  15401
UPMC Cancer Center -WashingtonWashington, Pennsylvania  15301
UPMC Cancer Center -WexfordWexford, Pennsylvania  15090