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Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Non-small Cell Lung Cancer

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Trial Information

Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer


The primary objective of this study is to evaluate the safety profile of Cetuximab when used
in combination with gemcitabine and carboplatin in patients with EGFr positive,
chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).

Also, the study will determine the response rate in patients with EGFr positive
chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in
combination with gemcitabine and carboplatin as well as determine the time to progression in
patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in
combination with gemcitabine and carboplatin.


Inclusion Criteria:



- Have a diagnosis of histologically/cytologically confirmed advanced non- small cell
lung cancer (NSCLC).

- Have uni-dimensionally measurable and/or evaluable advanced NSCLC.

- Have Stage IV or recurrent disease following radiation therapy.

- Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at
study entry.

- Have given signed informed consent.

- Be at least 18 years of age.

- Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to
100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or
equal to 9 g/dL.

- Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos,
AST and ALT less than or equal to 2.5 x upper limits of normal.

- Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine
clearance greater than or equal to 60 cc/minute.

- Be disease free from a previously treated malignancy for more than three years.
Patients with a history or a previous basal cell carcinoma of the skin or
pre-invasive carcinoma of the cervix will not be excluded.

- Agree to use effective contraception if procreative potential exists.

- Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.

Exclusion Criteria:

- Have received prior murine monoclonal antibody or Cetuximab therapy.

- Have disease amenable to curative surgery.

- Have received prior chemotherapy.

- Have received radiation therapy within 3 weeks prior to the first infusion of
Cetuximab.

- Have a history of clinically significant cardiac disease, serious arrhythmias, or
significant conduction abnormalities, in the judgment of the PI.

- Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher
neuropathy.

- Be pregnant or breast-feeding.

- Have received any investigational agent(s) within 1 month of study entry.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the tumor response of cetuximab in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, Stage IV non-small cell lung cancer.

Outcome Time Frame:

3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity

Safety Issue:

Yes

Principal Investigator

Francisco Robert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

X010524006

NCT ID:

NCT01004731

Start Date:

June 2001

Completion Date:

January 2006

Related Keywords:

  • Stage IV Non-Small Cell Lung Cancer
  • EGFr
  • cetuximab
  • gemcitabine
  • carboplatin
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300