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

NCT01004731 | Completed Phase 1 DMC

• 2 other identifiers: X010524006UAB 9909
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Non-Small Cell Lung Cancer

Keywords

EGFr; cetuximab; gemcitabine; carboplatin; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluate the response rate and time to disease progression

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

Study Arms (1)

Cetuximab in combination with Carboplatin/Gemcitabine

EXPERIMENTAL

Approximately 30 patients with advanced NSCLC will be enrolled. Patients will receive 3-week cycles of Cetuximab in combination with Carboplatin/Gemcitabine.

Drug: Cetuximab in combination with Carboplatin/Gemcitabine

Interventions

Cetuximab in combination with Carboplatin/Gemcitabine DRUG

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.

Cetuximab in combination with Carboplatin/Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Francisco Robert, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 30, 2009
• Study Start: June 1, 2001
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2006
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)