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An Exploratory Pharmacogenomics Study of Erbitux® Monotherapy in Patients With Metastatic Non-Small Cell Lung Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

An Exploratory Pharmacogenomics Study of Erbitux® Monotherapy in Patients With Metastatic Non-Small Cell Lung Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Safety Issue:

No

Principal Investigator

Fairooz F. Kabbinavar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000433489

NCT ID:

NCT00118118

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781