Full Text View
Tabular View
No Study Results Posted
Related Studies
Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
This study is currently recruiting participants.
Verified April 2011 by National Cancer Institute (NCI)

First Received on June 6, 2008.   Last Updated on April 7, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00693992
  Purpose

RATIONALE: Sunitinib 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 sunitinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying sunitinib to see how well it works when given as maintenance therapy compared with a placebo in treating patients with stage III or stage IV non-small cell lung cancer previously treated with combination chemotherapy.


Condition Intervention Phase
Lung Cancer
Drug: sunitinib malate
Other: placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade and type of toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 244
Study Start Date: June 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To compare the effect of sunitinib malate vs placebo on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer who have stable or responding disease after prior treatment with 4 courses of platinum-based therapy.

Secondary

  • To compare the toxicity of these regimens when administered in the maintenance setting.
  • To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting.
  • To compare the overall survival of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), disease stage (IIIB vs IV), prior treatment with bevacizumab (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral placebo once daily 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 every 3 months for 1 year, every 6 months for 1 year, and periodically for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)

    • Stage IIIB or IV disease
  • Not a candidate for combined modality therapy (chemoradiotherapy)
  • No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis

    • Patients with CNS metastases must be asymptomatic, 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
  • Must have received one prior first-line chemotherapy regimen that included 4 courses of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not have been given beyond the fourth course of chemotherapy)

    • Must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression
    • Completed the fourth course of first-line chemotherapy 3-5 weeks prior to study entry
  • Measurable or nonmeasurable disease

    • Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan
    • Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan), truly nonmeasurable lesions, and any of 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

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Granulocyte count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN (or ≤ 5 times ULN for patients with liver metastases)
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take oral medication
  • No history of QTc interval ≥ 500 msec within the past 2 years
  • No ongoing cardiac dysrhythmias or atrial fibrillation
  • No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident, or transient ischemic attack within the past year
  • No hypertension that cannot be controlled by medications (i.e., > 150/100 mm Hg despite optimal medical therapy)
  • No history of New York Heart Association (NYHA) class III-IV heart failure within the past 12 months

    • NYHA class I heart failure allowed
    • History of NYHA class II heart failure allowed provided at least one of the following criteria are met:

      • Asymptomatic on treatment
      • Previously treated with an anthracycline
      • Previously treated with central thoracic radiotherapy that included the heart in the radiotherapy port
  • 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 are eligible provided the hemoptysis amounts to < 5 mL of blood per episode and < 10 mL of blood per 24-hour period, in the best estimate of the investigator
  • No abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or serious or non-healing wound, ulcer, or bone fracture within the past 28 days
  • History of hypothyroidism allowed provided patient is currently euthyroid

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior adjuvant chemotherapy for resected stage I-III NSCLC or combined modality therapy for stage III NSCLC
  • No other prior primary therapy (including experimental therapy) for NSCLC
  • At least 1 week since prior palliative radiotherapy
  • More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

    • Azole antifungals (ketoconazole, itraconazole)
    • Diltiazem
    • Clarithromycin
    • Erythromycin
    • Verapamil
    • Delavirdine
    • HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
  • More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • Hypericum perforatum (St. John's wort)
    • Efavirenz
    • Tipranavir
  • No concurrent agents with proarrhythmic potential, including any of the following:

    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No concurrent therapeutic anticoagulation for thromboembolic disease

    • Concurrent low-dose coumadin (≤ 2 mg/day) allowed for prophylaxis of thrombosis
  • No concurrent chemotherapy or radiotherapy
  • No concurrent hormonal therapy, except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693992

  Show 337 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Mark A. Socinski, MD UNC Lineberger Comprehensive Cancer Center
Investigator: Nithya Ramnath, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00693992     History of Changes
Other Study ID Numbers: CDR0000597649, CALGB-30607
Study First Received: June 6, 2008
Last Updated: April 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012