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

Primary Purpose

Stage IV Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cetuximab in combination with Carboplatin/Gemcitabine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Non-Small Cell Lung Cancer focused on measuring EGFr, cetuximab, gemcitabine, carboplatin, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab in combination with Carboplatin/Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate the response rate and time to disease progression

Full Information

First Posted
October 21, 2009
Last Updated
May 24, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01004731
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-Small Cell Lung Cancer
Keywords
EGFr, cetuximab, gemcitabine, carboplatin, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab in combination with Carboplatin/Gemcitabine
Arm Type
Experimental
Arm Description
Approximately 30 patients with advanced NSCLC will be enrolled. Patients will receive 3-week cycles of Cetuximab in combination with Carboplatin/Gemcitabine.
Intervention Type
Drug
Intervention Name(s)
Cetuximab in combination with Carboplatin/Gemcitabine
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Robert, M.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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