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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCINCI-2009-00469
CDR0000597649, CALGB 30607, U10CA180821, U10CA031946, NCT00693992

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Mark Socinski, Principal Investigator

    Trial Sites

    U.S.A.

    California
    Los Angeles

    Kaiser Permanente Medical Center - Los Angeles

    Han A Koh
    Ph: 626-564-3455

    Paradise

    Feather River Hospital Cancer Center

    Sam Mazj
    Ph: 530-876-7995
    Email: haleew@ah.org

    San Diego

    Kaiser Permanente - Mission

    Han A Koh
    Ph: 626-564-3455

    Connecticut
    Hartford

    Helen and Harry Gray Cancer Center at Hartford Hospital

    Robert D. Siegel
    Ph: 860-545-5363

    Florida
    Fort Lauderdale

    Broward General Medical Center Cancer Center

    Barry S Berman
    Ph: 954-355-5346

    Illinois
    Alton

    Saint Anthony's Hospital at Saint Anthony's Health Center

    Bethany G. Sleckman
    Ph: 913-948-5588

    Indiana
    Fort Wayne

    Fort Wayne Medical Oncology and Hematology

    Sreenivasa Rao Nattam
    Ph: 260-484-8830
    Email: ledgar@fwmoh.com

    Indianapolis

    St. Vincent Indianapolis Hospital

    Ruemu E Birhiray
    Ph: 317-338-2194

    Massachusetts
    Attleboro

    Sturdy Memorial Hospital

    Colleen K Yavarow
    Ph: 508-236-7059

    Minnesota
    Mankato

    Immanuel St. Joseph's

    Mohmmad J Ranginwala
    Ph: 507-385-2929

    Missouri
    Saint Louis

    CCOP - St. Louis-Cape Girardeau

    Bethany G. Sleckman
    Ph: 913-948-5588

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Maria Q. Baggstrom
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    New Hampshire
    Exeter

    Center for Cancer Care at Exeter Hospital

    Michael S Buff
    Ph: 800-339-6484

    New York
    Cooperstown

    Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

    Eric Bravin
    Ph: 607-547-6965
    Email: jennifer.victory@bassett.org

    Glens Falls

    Charles R. Wood Cancer Center at Glens Falls Hospital

    Aqeel A Gillani
    Ph: 518-926-6700

    North Dakota
    Bismarck

    Bismarck Cancer Center

    Edward J. Wos
    Ph: 701-323-5760
    Email: tfischer@mohs.org

    Ohio
    Akron

    McDowell Cancer Center at Akron General Medical Center

    Esther H. Rehmus
    Ph: 330-344-6348

    Canton

    Mercy Cancer Center at Mercy Medical Center

    Mitchell Haut
    Ph: 888-293-4673

    Oklahoma
    Oklahoma City

    Stephenson Cancer Center at the University of Oklahoma

    Shubham Pant
    Ph: 405-271-4272
    Email: julie-traylor@ouhsc.edu

    Oregon
    Salem

    Salem Hospital Regional Cancer Care Services

    Edward Peter Orlowski
    Ph: 503-561-2618

    South Dakota
    Sioux Falls

    Sanford Cancer Center at Sanford USD Medical Center

    Miroslaw A Mazurczak
    Ph: 605-328-1367

    Miroslaw A Mazurczak
    Ph: 605-328-1367

    Texas
    Houston

    Ben Taub General Hospital

    Martha P Mims
    Ph: 713-798-1354
    Email: burton@bcm.edu

    Dan L. Duncan Cancer Center at Baylor College of Medicine

    Martha P Mims
    Ph: 713-798-1354
    Email: burton@bcm.edu

    St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

    Martha P Mims
    Ph: 713-798-1354
    Email: burton@bcm.edu

    Veterans Affairs Medical Center - Houston

    Martha P Mims
    Ph: 713-798-1354
    Email: burton@bcm.edu

    Wisconsin
    La Crosse

    Gundersen Lutheran Center for Cancer and Blood

    Kurt Oettel
    Ph: 608-775-2385
    Email: cancerctr@gundluth.org

    Mequon

    Columbia Saint Mary's Hospital - Ozaukee

    Charles H. I. Tiber
    Ph: 414-326-2675
    Email: clinicaltrials@columbia-stmarys.org

    Milwaukee

    Columbia-Saint Mary's Cancer Care Center

    Charles H. I. Tiber
    Ph: 414-326-2675
    Email: clinicaltrials@columbia-stmarys.org

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00693992
    ClinicalTrials.gov processed this data on May 21, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.