Cetuximab in Treating Patients With Recurrent or Progressive Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118118
First received: July 8, 2005
Last updated: February 6, 2009
Last verified: April 2006
  Purpose

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

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or progressive metastatic non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Pharmacogenomics Study of Erbitux® Monotherapy in Patients With Metastatic Non-Small Cell Lung Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Study Start Date: March 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine whether expression of Calgranulin B, E-Cadherin, S100P, FXYD domain containing 3, Cathepsin B, and/or Serpin E2 can predict response to cetuximab in patients with recurrent or progressive metastatic non-small cell lung cancer.

Secondary

  • Determine whether additional genes can be identified, using microarray analysis and panels of candidate genes for involvement in cancer, that are predictive of response to this drug in these patients.
  • Determine whether proteins discovered in serum can predict tumor response to this drug in these patients.
  • Correlate CA repeats, single nucleotide polymorphisms, or mutations of genes within the epidermal growth factor receptor pathway with response to this drug in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive cetuximab IV over 1-2 hours once weekly for 8 weeks. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for at least 30 days, every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Metastatic disease
    • Recurrent or progressive disease
  • Tumor must be accessible to biopsy or fine needle aspiration
  • Unidimensionally measurable disease
  • Received ≥ 1 prior platinum-based combination chemotherapy regimen for recurrent or progressive disease
  • Asymptomatic brain metastasis allowed provided patient completed radiotherapy and/or radiosurgery ≥ 3 weeks ago AND is off steroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT and/or INR ≤ 10% above ULN

Renal

  • Creatinine ≤ 2 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No uncontrolled arrhythmia
  • No other significant cardiac disease

Neurologic

  • No uncontrolled seizure disorder
  • No active neurological disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for ≥ 4 weeks after completion of study treatment
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not a prisoner
  • Not compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior antibody therapy that targets the epidermal growth factor receptor (EGFR)

Chemotherapy

  • See Disease Characteristics
  • More than 30 days since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy
  • No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after radiotherapy
  • Prior local radiotherapy for the management of tumor-related symptoms allowed

Surgery

  • More than 30 days since prior major thoracic or abdominal surgery and recovered

Other

  • Prior therapy with EGFR tyrosine kinase inhibitors allowed
  • More than 30 days since prior investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118118

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00118118     History of Changes
Other Study ID Numbers: CDR0000433489, UCLA-0409029-01, BMS-CA225065
Study First Received: July 8, 2005
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014