Status:
COMPLETED
Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more tumor cells. PURPOSE...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of everolimus when administered with gefitinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer. (Phase I) * Deter...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
- Stage IIIB (unresectable, with malignant pleural or pericardial effusion)
- Stage IV disease
- Recurrent disease
- Measurable or evaluable indicator lesions
- Progressive disease after receiving ≥ 1 prior chemotherapy regimen that included cisplatin or carboplatin and docetaxel
- No uncontrolled brain or leptomeningeal metastases
- Must not require concurrent glucocorticoids for control of metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 70-100% OR
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No congestive heart failure
- No New York Heart Association class III or IV heart disease
- No unstable angina
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe infection
- No severe malnutrition
- No other serious medical illness
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent biologic therapy
- No concurrent immunotherapy
- Chemotherapy
- See Disease Characteristics
- No prior conventional chemotherapy for metastatic or recurrent NSCLC (phase II only)
- At least 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- No concurrent oral steroids for management of skin toxicity
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- At least 4 weeks since prior major surgery
- No concurrent surgery for an identifiable lesion
- Other
- Recovered from all prior therapy
- No prior gefitinib, erlotinib, or other epidermal growth factor tyrosine kinase inhibitor
- No concurrent cytotoxic therapy (e.g., methotrexate for rheumatoid arthritis)
- No other concurrent oncolytic agents
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00096486
Start Date
May 1 2004
End Date
July 1 2010
Last Update
January 21 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021