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A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer


Lung cancer is the second most common cancer diagnosed for both genders in the United
States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of
cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004.
Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced
disease is limited. The study will test two chemotherapy agents, carboplatin and
paclitaxel, in combination with a newly approved drug called cetuximab, which is continuing
to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody,
which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on
tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the
EGFR. Fifty percent of lung cancers overexpress EGFR.

Rationale:

The present study is built upon the data from previous studies, incorporating cetuximab into
each of two regimens of paclitaxel plus carboplatin. The results of prior studies using
paclitaxel and carboplatin demonstrate that these drugs in combination, using a variety of
schedules, are both safe and effective as therapy for advanced or metastatic NSCLC. The
addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will
presumably maximize the therapeutic index while keeping toxicity to a minimum in patients
with Stage IIIB/IV NSCLC.

Research Hypothesis:

Subjects with previously-untreated stage IIIB/IV NSCLC who receive a combination of
paclitaxel, carboplatin, and cetuximab will have a progression-free survival rate greater
than that previously reported for subjects receiving the combination of paclitaxel and
carboplatin.


Inclusion Criteria:



To be eligible for the study, subjects must fulfill all of the following criteria and have
a complete signed informed consent form.

- Subjects must have signed an approved informed consent.

- Subjects with histologically or cytologically documented stage IIIB (supraclavicular
lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease
must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.

- Subjects with measurable disease.

- Subjects with ECOG performance status 0-1.

- Subjects with asymptomatic brain metastasis are eligible; however, they must have
completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off
steroids.

- Radiotherapy must have been completed > 2 weeks prior to enrollment and the subject
must have recovered from all adverse effects of prior radiotherapy. No previous
irradiation to the only area of measurable disease. New lesions that developed in a
previously irradiated area will be allowed.

- If diagnostic tissue or slides are available for a subject, these must be submitted
for testing of EGFR status.

- Subjects ≥18 years of age.

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 4 weeks after the
study in such a manner that the risk of pregnancy is minimized. WOCBP include any
female who has experienced menarche and who has not undergone successful surgical
sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or
is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on
hormone replacement therapy (HRT) with documented serum follicle stimulating hormone
(FSH) level >35mIU/mL]. Even women who are using oral, implanted or injectable
contraceptive hormones or mechanical products such as an intrauterine device or
barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or where partner is sterile (e.g., vasectomy), should be considered to be
of child bearing potential. WOCBP must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the
start of study medication.

- Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC

≥3,000/mm 3 ; platelets ≥100,000/mm 3 ; and hemoglobin ≥9 g/dL.

- Subjects with adequate hepatic function defined as: total bilirubin ≤1.5 x upper
limit of normal (ULN) or AST ≤2.5 x ULN.

- Subjects with adequate renal function defined as a serum creatinine level ≤1.5 mg/dL
or a creatinine clearance ≥60 cc/minute.

Exclusion Criteria:

Any of the following criteria will make the subject ineligible to participate in this
study.

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for up to 4 weeks after the study. Subjects who are men
must also agree to use effective contraception.

- WOCBP using a prohibited contraceptive method.

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to study drug
administration.

- Subjects who have had prior malignancy, except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
subject has been disease-free for 5 years.

- Subjects with significant history of cardiac disease, i.e., uncontrolled
hypertension, unstable angina, uncontrolled congestive heart failure, cardiomyopathy
with decreased ejection fraction, myocardial infarction within the past year, or
cardiac ventricular arrythmias requiring medication.

- Subjects with an uncontrolled seizure disorder, or active neurological disease.

- Subjects with symptomatic brain metastasis. Prohibited Therapies and/or Medications

- Subjects who have received prior systemic chemotherapy. Subjects with no more than
one prior adjuvant regimen for initially diagnosed disease are eligible for the
study.

- Subjects with a history of prior cetuximab or other therapy that specifically and
directly targets the EGFR pathway.

- Subject with prior severe infusion reaction to a monoclonal antibody.

- Subjects with know allergy to Cremophor EL.

- Subjects with known peripheral neuropathy (> grade 1).

- Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment.

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate median progression free survival and the progression free survival rate

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

CA225-058

NCT ID:

NCT00097227

Start Date:

November 2004

Completion Date:

April 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • non-small
  • lung
  • IIIb
  • IV
  • Carboplatin
  • Paclitaxel
  • Cetuximab
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

ImClone Investigational SiteIndianapolis, Indiana  46202
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteLouisville, Kentucky  40202
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteVoorhees, New Jersey  08043
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SiteWinston-Salem, North Carolina  27103
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteNewark, Delaware  19713
ImClone Investigational SiteMorgantown, West Virginia  26506