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Sunitinib Malate as Maintenan...

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Last Updated: 2019-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-15

Study Completion Date

2015-05-28

Brief Summary

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This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.

II. To evaluate the additional response rate as a result of sunitinib in this setting.

III. To assess the impact of sunitinib on overall survival compared to the placebo arm.

IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).

V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Conditions

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Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm I (sunitinib malate)

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Sunitinib Malate

Intervention Type DRUG

Given PO

Arm II (placebo)

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Placebo

Intervention Type OTHER

Given PO

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Placebo

Given PO

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Sunitinib Malate

Given PO

Intervention Type DRUG

Other Intervention Names

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placebo therapy PLCB sham therapy Quality of Life Assessment SU011248 SU11248 sunitinib Sutent

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic documentation of primary non-small cell lung cancer
* Stage IIIB or IV disease patients who are not candidates for combined modality therapy (chemoradiotherapy)
* No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis; patients with central nervous system (CNS) metastases must be asymptomatic, must have received definitive therapy (\>= 6 weeks since resection or \>= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
* No cavitary lesions
* Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the regimen must include four cycles of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not be given beyond the fourth cycle of chemotherapy); patients must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of prior therapy
* No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality therapy for stage III NSCLC
* No other primary therapy (including experimental therapy) for NSCLC; palliative radiation therapy must have been completed at least one week before planned start of protocol therapy
* Patients must have measurable or non-measurable disease

* Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan
* Non-measurable disease: all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:

* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Non-pregnant and non-nursing
* No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT (QTc) interval \>= 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
* Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:

* Patients with a history of class II heart failure who are asymptomatic on treatment
* Patients with prior anthracycline exposure
* Patients who have received central thoracic radiation that included the heart in the radiotherapy port
* Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
* Patients with hypertension that cannot be controlled by medications (\> 150/100 mmHg despite optimal medical therapy) are not eligible
* Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
* No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
* No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of blood per 24-hour period in the best estimate of the investigator
* Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
* None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
* The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days before beginning and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus \[HIV\] protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John?s Wort, efavirenz, tipranavir; other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
* Patients unable to take oral medication are not eligible
* Granulocytes \>= 1,500/mcl
* Platelet count \>= 100,000/mcl
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=\< 2.5 x ULN; patients with liver metastases may have AST and ALT =\< 5 x ULN; all other patients will have AST and ALT =\< 2.5 x ULN
* Creatinine =\< 1.5 mg/dl

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark A Socinski

Role: PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Locations

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Northeast Alabama Regional Medical Center

Anniston, Alabama, United States

Site Status

Providence Hospital

Mobile, Alabama, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Veteran's Administration Medical Center

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Site Status

Feather River Cancer Center

Chico, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Kaiser Permanente-Fontana

Fontana, California, United States

Site Status

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Site Status

Kaiser Permanente - Harbor City

Harbor City, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

Long Beach Memorial Medical Center-Todd Cancer Institute

Long Beach, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Cadillac

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

El Camino Hospital

Mountain View, California, United States

Site Status

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Site Status

Tom K Lee Inc

Oakland, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Kaiser Permanente - Panorama City

Panorama City, California, United States

Site Status

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Site Status

Valley Medical Oncology Consultants

Pleasanton, California, United States

Site Status

Kaiser Permanente-Riverside

Riverside, California, United States

Site Status

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Site Status

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Site Status

Naval Medical Center -San Diego

San Diego, California, United States

Site Status

Kaiser Permanente-San Marcos

San Marcos, California, United States

Site Status

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Site Status

Saint Helena Hospital

St. Helena, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

Northbay Cancer Center

Vacaville, California, United States

Site Status

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Middlesex Hospital

Middletown, Connecticut, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

Howard University Hospital

Washington D.C., District of Columbia, United States

Site Status

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Site Status

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

AdventHealth Orlando

Orlando, Florida, United States

Site Status

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status

Saint Anthony's Health

Alton, Illinois, United States

Site Status