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NCT Number: NCT01004731

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.

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Key information

Conditions

Stage IV Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2006
First posted
Oct 30, 2009
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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