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Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087412
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of OSI-774 (NSC-718781) In Patients With Advanced Non-Small Cell Lung Cancer And A Performance Status Of 2

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

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Functional and symptom status [ Designated as safety issue: No ]
  • Correlation of epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival [ Designated as safety issue: No ]
  • Correlation of activated signal pathway molecules with response and/or survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (confirmed, unconfirmed, complete, or partial response) rate [ Designated as safety issue: No ]

Study Start Date: September 2004
Detailed Description:

OBJECTIVES:

  • Determine survival of patients with advanced primary non-small cell lung cancer and a Zubrod performance status of 2 treated with erlotinib.
  • Determine the objective tumor response rates (confirmed, unconfirmed, complete, or partial) in patients treated with this drug.
  • Determine functional and symptom status in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Correlate, preliminarily, epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival in patients treated with this drug.
  • Correlate, preliminarily, activated signal pathway molecules, including basal p27 expression levels, with response and/or survival in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:

    • Selected stage IIIB disease (excluding Pancoast tumors)

      • T4 lesion due to malignant pleural effusion only
      • Any N
      • M0
    • Stage IV disease

      • Any T
      • Any N
      • M1
    • Recurrent disease after prior surgery and/or radiotherapy
  • The following histologies are eligible:

    • Adenocarcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
    • Unspecified
  • Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam

    • Measurable disease must be outside prior irradiated fields OR a new lesion must be present
    • Measurable disease must be outside the area of prior surgical resection
  • No brain metastases

    • Negative CT scan or MRI if there are neurological abnormalities on physical exam or symptoms
  • Patients must be offered participation in protocol SWOG-S9925 (Lung Cancer Specimen Repository study)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:

    • Alkaline phosphatase ≤ ULN AND SGOT OR SGPT ≤ 2 times ULN
    • Alkaline phosphatase ≤ 4 times ULN AND SGOT OR SGPT ≤ ULN

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No significant history of cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure
  • No cardiac ventricular arrhythmias requiring medication
  • No myocardial infarction within the past 6 months

Gastrointestinal

  • No GI tract disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No requirement for IV alimentation

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for NSCLC
  • No concurrent biologic therapy

Chemotherapy

  • No prior systemic chemotherapy for NSCLC

Endocrine therapy

  • No prior hormonal therapy for NSCLC
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to measurable or non-measurable lesions

    • Concurrent palliative radiotherapy to small-field non-measurable sites of painful bony metastases allowed provided there are other sites of measurable disease outside of the radiotherapy treatment field

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior thoracic or other major surgeries and recovered
  • No prior surgical procedures affecting gastrointestinal (GI) absorption

Other

  • No prior epidermal growth factor receptor inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087412

  Show 128 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Paul J. Hesketh, MD Caritas St. Elizabeth's Medical Center of Boston
Investigator: Antoinette J. Wozniak, MD Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Hesketh PJ, Chansky K, Wozniak AJ, Hirsch FR, Spreafico A, Moon J, Mack PC, Marchello BT, Franklin WA, Crowley JJ, Gandara DR. Southwest Oncology Group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2. J Thorac Oncol. 2008 Sep;3(9):1026-31.
Hesketh PJ, Chansky K, Wozniak AJ, et al.: Erlotinib as initial therapy in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2: a SWOG phase II trial (S0341). [Abstract] J Clin Oncol 25 (Suppl 18): A-7536, 393s, 2007.

Study ID Numbers: CDR0000377245, SWOG-S0341
Study First Received: July 8, 2004
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00087412  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009