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

May 24, 2023 updated by: Michael James Bertram, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetuximab in combination with Carboplatin/Gemcitabine
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Francisco Robert, M.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimated)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X010524006
  • UAB 9909 (Other Identifier: UAB Department study number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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