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Cetuximab in Treating Patient...

Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

Last Updated: 2023-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-13

Study Completion Date

2012-08-31

Brief Summary

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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab.

Secondary

* Determine the overall survival and time to progression in patients treated with this drug.
* Determine the toxic effects of this drug in these patients.
* Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug.
* Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.

Conditions

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Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab

Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

Interventions

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cetuximab

Intervention Type BIOLOGICAL

Other Intervention Names

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C225

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:

* Stage IIIB disease (with pleural or pericardial effusion)
* Stage IV disease
* Recurrent disease
* Measurable disease
* Tumor tissue available from biopsy
* Age of 18 and over
* ECOG performance status of 0-2
* Life expectancy greater than 3 months
* White blood cell (WBC) ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal
* Creatinine normal OR Creatinine clearance ≥ 60 mL/min
* No more than 1 prior chemotherapy regimen for advanced BAC
* More than 3 years since prior chemotherapy for other malignancies
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered
* HIV-positive patients are eligible provided the following criteria are met:

* CD4 count ≥ 100/mm\^3
* Undetectable viral load within the past 3 months
* Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry
* Fertile patients must use effective contraception
* At least 2 weeks since prior radiotherapy and recovered

Exclusion Criteria

* Untreated brain metastases

* Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible
* Acute hepatitis
* Symptomatic congestive heart failure
* Uncontrolled hypertension
* Unstable angina pectoris
* Cardiac arrhythmia
* Pregnant or nursing
* Prior allergic reaction to chimerized or murine monoclonal antibody therapy
* Documented presence of human anti-mouse antibodies
* Ongoing or active infection
* Psychiatric illness or social situation that would preclude study compliance
* Other uncontrolled illness
* Prior cetuximab
* Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
* Other concurrent investigational agents
* Other concurrent anticancer therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suresh Ramalingam, MD

Role: STUDY_CHAIR

Emory Winship Cancer Institute

Locations

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Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

Boca Raton, Florida, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status