CompletedPhase 1 / Phase 2NCT00096486

Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer

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.

Checked against the public recordLast updated Jan 21, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations1
SponsorMemorial Sloan Kettering Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: everolimus; Drug: gefitinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan-Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 21, 2016. Always confirm current availability with the study team.

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