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

Sponsor:	University of Alabama at Birmingham
Collaborator:	ImClone LLC
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01004731

Purpose

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.

Condition	Intervention	Phase
Stage IV Non-small Cell Lung Cancer	Drug: Cetuximab in combination with Carboplatin/Gemcitabine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Epidermal Growth Factor Gemcitabine Gemcitabine hydrochloride Cetuximab

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

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. [ Time Frame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	June 2001
Study Completion Date:	January 2006
Primary Completion Date:	January 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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

Assigned Interventions

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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004731

Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

ImClone LLC

Investigators

Principal Investigator:

Francisco Robert, M.D.

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Francisco Robert, M.D. )
Study ID Numbers:	X010524006, UAB 9909
Study First Received:	October 21, 2009
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT01004731 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

EGFr
cetuximab
gemcitabine
carboplatin
NSCLC

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Mitogens
Gemcitabine
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Cetuximab
Mitosis Modulators
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009