Phase 2
N=74
Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00096486 ↗Enrolled (actual)
74
Serious AEs
31.1%
Results posted
Jan 2016
Primary outcome: Primary: Overall Objective Response — 1; 1; 3; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- everolimus (Drug); gefitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Objective Response |
1; 1; 3; 2; 1; 1 | — |
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: This phase I/II trial is studying the side effects, best way to give, and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00096486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.