Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Eli Lilly and Company; ImClone LLC
• Treatments: Antibodies; Carboplatin; Cetuximab; Gemcitabine; Mitogens

Criteria

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.