Clinical trial

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

Name

X010524006

Description

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.

Trial arms

Trial start

2001-06-01

Estimated PCD

2002-01-01

Trial end

2006-01-01

Status

Completed

Phase

Early phase I

Treatment

Cetuximab in combination with Carboplatin/Gemcitabine

A loading dose of Cetuximab (400 mg/m2 IV over 120 minutes) will be administered 1 week prior to chemotherapy. Thereafter, Cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each new cycle of therapy, Carboplatin will be infused with Gemcitabine (Days 1 and 8). Patients will be evaluated for a tumor response following every two cycles of therapy. In the absence of progressive disease, patients may continue to receive additional therapy.

Arms:

Cetuximab in combination with Carboplatin/Gemcitabine

Size

Primary endpoint

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.

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

Updated at

2023-05-25

1 organization

1 product

1 indication

Organization

University of Alabama at Birmingham

Product

Cetuximab

Indication

Stage IV Non-Small Cell Lung Cancer