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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedeverolimus and gefitinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

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

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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