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

NCT00096486 | Completed Phase 1 Results

• 2 other identifiers: 04-033MSKCC-04033
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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: 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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response

  Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).

  2 years

Study Arms (1)

Gefitinib and Everolimus (RAD001)

EXPERIMENTAL

Phase I: Patients receive oral everolimus once on day 1. Beginning on day 8, patients receive oral gefitinib once daily. Beginning on day 22, patients receive oral everolimus once daily. Both drugs are then given concurrently for the rest of the treatment. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. * Phase II: Patients receive oral everolimus at the MTD determined in phase I and oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: everolimus; Drug: gefitinib

Interventions

everolimus DRUG

Gefitinib and Everolimus (RAD001)

gefitinib DRUG

Gefitinib and Everolimus (RAD001)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Price KA, Azzoli CG, Krug LM, Pietanza MC, Rizvi NA, Pao W, Kris MG, Riely GJ, Heelan RT, Arcila ME, Miller VA. Phase II trial of gefitinib and everolimus in advanced non-small cell lung cancer. J Thorac Oncol. 2010 Oct;5(10):1623-9. doi: 10.1097/JTO.0b013e3181ec1531.

  PMID: 20871262 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Everolimus; Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mark Kris
• Organization: Memorial Sloan Kettering Cancer Center

krism@mskcc.org

646-888-4205

Study Officials

• Vincent A. Miller, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 10, 2004
• Study Start: May 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 21, 2016
• Results First Posted: January 21, 2016

Record last verified: 2015-12

Locations

US (1)