Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer
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.
Checked against the public recordLast updated May 25, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Alabama at Birmingham
- Interventions being studied
- Drug: Cetuximab in combination with Carboplatin/Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 25, 2023. Always confirm current availability with the study team.