Status:
COMPLETED
Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways t...
Detailed Description
OBJECTIVES: * Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose e...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed non-small cell lung cancer
- Stage IIIB or IV or recurrent disease
- Measurable or evaluable indicator lesions
- Must have smoked ≥ 100 cigarettes in his/her lifetime
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- WBC ≥ 4,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
- No gastrointestinal tract disease or inability to take oral medication
- No prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other active medical problems, including severe infection, unstable angina, or myocardial infarction within the past 6 months
- No poorly controlled hypertension or severe malnutrition
- No New York Heart Association class III or IV congestive heart failure or serious cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia)
- PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy to major bone marrow-containing sites
- No prior chemotherapy for advanced non-small cell lung cancer
- No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis (e.g., gefitinib, cetuximab, or trastuzumab \[Herceptin®\])
- No prior surgical procedure resulting in abnormal absorption of oral medications
- No concurrent surgical resection, palliative radiotherapy, or hormonal therapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00287989
Start Date
November 1 2004
End Date
May 1 2009
Last Update
December 6 2018
Active Locations (2)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021