Lung Cancer Clinical Trial

Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Summary

This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more effective when given alone or together in treating non-small cell lung cancer.

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Full Description

PRIMARY OBJECTIVES:

I. To estimate the 18 week progression-free survival rate of pemetrexed (pemetrexed disodium) alone (Arm I), sunitinib (sunitinib malate) alone (Arm II) and pemetrexed plus sunitinib (Arm III) in the second-line setting of advanced non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To compare the progression-free survival of the three arms. II. To estimate the response rate, duration of response, rate of stable disease, overall survival and to characterize the toxicity profiles of the three arms.

III. To estimate the response rate, duration of response, rate of stable disease, overall survival and toxicity of sunitinib in those patients on Arm I that receive this regimen in the third line setting.

IV. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer.

V. To test change in tumor size at 6 weeks (after 2 cycles of therapy, typically the first evaluation point in this type of study) as an early predictor of therapeutic activity in second-line treatment of non-small cell lung cancer.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.

ARM II: 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. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.

ARM III: Patients receive pemetrexed disodium IV over 10 minutes on day 1 and sunitinib malate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 weeks until disease progression and then every 6 months for 2 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologic documentation: histologic or cytologic documentation of NSCLC
Stage: IIIB/IV with evidence of disease progression following first-line therapy
Tumor site: lung (non-small cell)
No cavitary lesions
Only one prior chemotherapy regimen in the first-line stage IIIB/IV setting is allowed; this could have been either a platinum- or non-platinum-based regimen
First-line therapy must be completed >= 28 days before registration
Prior adjuvant therapy is allowed provided the patient had one previous regimen in the advanced stage IIIB/IV setting
At least 28 days from prior major surgery and at least 14 days from any prior radiotherapy before registration
No prior inhibitors of VEGF receptor (VEGFR) (e.g., SU5416, SU6668, AZ6474, SU11248, PTK787, AZD2171, AEE-788, sorafenib); prior treatment with epidermal growth factor receptor (EGFR) inhibitors and bevacizumab is allowed, provided at least 4 weeks has elapsed
No prior pemetrexed

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 nonmeasurable 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 0-1
Pregnant or nursing mothers are not eligible for this study; patients in their child bearing years must have a baseline negative pregnancy test (in the case of females); males and females must practice appropriate contraceptive measures during the period of protocol therapy and for 6 months after completion of protocol therapy; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT interval (QTc interval) > 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, 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 symptomatic congestive heart failure within 12 months prior to entry 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 or hyperthyroidism 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 use of the following specific inhibitors and inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of CYP3A4 are prohibited within 7 days before 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
No symptomatic or untreated central nervous system (CNS) metastases; patients with 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 chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal antiinflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed
No pleural effusions or ascites that are detectable on physical exam

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT00698815

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 112 Locations for this study

See Locations Near You

Kaiser Permanente-Anaheim
Anaheim California, 92807, United States
Arroyo Grande Community
Arroyo Grande California, 93420, United States
Kaiser Permanente-Baldwin Park
Baldwin Park California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower California, 90706, United States
East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Eden Hospital Medical Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville California, 94608, United States
Kaiser Permanente Hospital
Fontana California, 92335, United States
Valley Medical Oncology Consultants-Fremont
Fremont California, 94538, United States
Kaiser Permanente - Harbor City
Harbor City California, 90710, United States
Kaiser Permanente-Irvine
Irvine California, 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles California, 90027, United States
Kaiser Permanente-Cadillac
Los Angeles California, 90034, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
El Camino Hospital
Mountain View California, 94040, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland California, 94609, United States
Tom K Lee Inc
Oakland California, 94609, United States
Kaiser Permanente - Panorama City
Panorama City California, 91402, United States
PCR Oncology
Pismo Beach California, 93449, United States
Valley Care Health System - Pleasanton
Pleasanton California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton California, 94588, United States
Kaiser Permanente-Riverside
Riverside California, 92505, United States
University of California San Diego
San Diego California, 92103, United States
Kaiser Permanente-San Diego Mission
San Diego California, 92108, United States
Kaiser Permanente-San Diego Zion
San Diego California, 92120, United States
Kaiser Permanente-San Marcos
San Marcos California, 92069, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo California, 94806, United States
Kaiser Permanente
Woodland Hills California, 91367, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Middlesex Hospital
Middletown Connecticut, 06457, United States
Norwalk Hospital
Norwalk Connecticut, 06856, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Jupiter Medical Center
Jupiter Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Jesse Brown Veterans Affairs Medical Center
Chicago Illinois, 60612, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Joliet Oncology-Hematology Associates Limited
Joliet Illinois, 60435, United States
AMITA Health Adventist Medical Center
La Grange Illinois, 60525, United States
Elkhart Clinic
Elkhart Indiana, 46514, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Community Howard Regional Health
Kokomo Indiana, 46904, United States
IU Health La Porte Hospital
La Porte Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville Indiana, 46391, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf Iowa, 52722, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Iowa City VA Healthcare System
Iowa City Iowa, 52246, United States
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford Massachusetts, 01757, United States
Newton-Wellesley Hospital
Newton Massachusetts, 02462, United States
Lakeland Community Hospital
Niles Michigan, 49120, United States
Lakeland Hospital
Saint Joseph Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City Missouri, 65109, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
Comprehensive Cancer Care PC
Saint Louis Missouri, 63141, United States
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
Nebraska Cancer Research Center
Lincoln Nebraska, 68510, United States
Great Plains Regional Medical Center
North Platte Nebraska, 69103, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas Nevada, 89106, United States
Exeter Hospital
Exeter New Hampshire, 03833, United States
LRGHealthcare-Lakes Region General Hospital
Laconia New Hampshire, 03246, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse New York, 13057, United States
Glens Falls Hospital
Glens Falls New York, 12801, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Northwell Health/Center for Advanced Medicine
New Hyde Park New York, 11040, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
Syracuse Veterans Administration Medical Center
Syracuse New York, 13210, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
Kinston Medical Specialists PA
Kinston North Carolina, 28501, United States
Annie Penn Memorial Hospital
Reidsville North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville North Carolina, 28677, United States
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Washington North Carolina, 27889, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington North Carolina, 28401, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Memorial Hospital of Rhode Island
Pawtucket Rhode Island, 02860, United States
Greenville Health System Cancer Institute-Easley
Easley South Carolina, 29640, United States
McLeod Regional Medical Center
Florence South Carolina, 29506, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Greenville Health System Cancer Institute-Andrews
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Butternut
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Faris
Greenville South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville South Carolina, 29615, United States
Self Regional Healthcare
Greenwood South Carolina, 29646, United States
Greenville Health System Cancer Institute-Greer
Greer South Carolina, 29650, United States
Greenville Health System Cancer Institute-Seneca
Seneca South Carolina, 29672, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg South Carolina, 29307, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Vermont, 05602, United States
University of Vermont College of Medicine
Burlington Vermont, 05405, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Memorial Hospital Of Martinsville
Martinsville Virginia, 24115, United States
Saint Mary's Medical Center
Huntington West Virginia, 25702, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT00698815

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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