Status:
COMPLETED
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients ...
Detailed Description
OBJECTIVES: Primary * Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)
- Stage IIIB (malignant pleural or pericardial effusion) disease
- Stage IV disease
- Recurrent and/or medically inoperable disease
- Measurable or evaluable indicator lesions
- No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
- Life expectancy ≥ 8 weeks
- WBC ≥ 3,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.0 mg/dL
- AST ≤ 2 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No significant medical history or unstable medical condition, including any of the following:
- Unstable systemic disease
- Congestive heart failure
- Recent myocardial infarction
- Unstable angina
- Active infection
- Uncontrolled hypertension
- No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
- At least 3 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen for NSCLC
- No prior systemic cytotoxic chemotherapy for other malignant diseases
- No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib)
- No concurrent radiotherapy or chemotherapy
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00416650
Start Date
July 1 2002
End Date
March 1 2013
Last Update
April 4 2013
Active Locations (4)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030