Clinical trial NCT01004731: Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage IV Non-Small Cell Lung Cancer
Keywords: EGFr
cetuximab
gemcitabine
carboplatin
NSCLC
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-10-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity
Secondary outcomes:
measure: Evaluate the response rate and time to disease progression
timeFrame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Francisco Robert, M.D.
role: PRINCIPAL_INVESTIGATOR
References: