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Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392444
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : December 13, 2013
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 25, 2006
First Posted Date  ICMJE October 26, 2006
Results First Submitted Date  ICMJE October 21, 2013
Results First Posted Date  ICMJE December 13, 2013
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Objective Response (Partial and Complete) Per RECIST [ Time Frame: Up to 3 years ]
Number of patients who had objective responses after radiology review
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
Official Title  ICMJE A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma
Brief Summary This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
Detailed Description

PRIMARY OBJECTIVES:

I. Assess the efficacy of sunitinib malate, in terms of response rate (complete and partial), in patients with malignant pleural mesothelioma.

II. Assess the toxicity, safety, and tolerability of this drug in these patients.

III. Assess the duration of response or stable disease, stable disease rate, progression-free survival, and median and overall survival rates.

OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignant Mesothelioma
  • Recurrent Malignant Mesothelioma
Intervention  ICMJE Drug: sunitinib malate
Given orally
Other Names:
  • SU11248
  • sunitinib
  • Sutent
Study Arms  ICMJE Experimental: Treatment (sunitinib malate)
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: sunitinib malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2013)
39
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Criteria:

  • Histologically or cytologically confirmed malignant pleural mesothelioma; Advanced or metastatic disease incurable by standard therapies
  • Measurable disease, defined as at least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan; No sole site of disease in a previously irradiated area unless there has been subsequent evidence of progression; Low-dose, palliative radiotherapy allowed
  • Meets 1 of the following criteria for prior cytotoxic chemotherapy treatment: Previously treated with 1 platinum-based chemotherapy regimen; Previously untreated (i.e., no prior cytotoxic chemotherapy)
  • No known brain metastases
  • ECOG performance status 0-1
  • Life expectancy >= 12 weeks
  • Platelet count >= 100,000/mm^3
  • Absolute granulocyte count >= 1,500/mm^3
  • Bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal
  • Calcium =< 3 mmol/L
  • Creatinine normal OR creatinine clearance >= 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients must reside within a 1.5 hour drive from participating center
  • Able to take oral medication
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix, or any other curatively treated solid tumor
  • No known history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
  • No QTc prolongation (i.e., QTc interval >= 500 msec) or other significant ECG abnormalities
  • No New York Heart Association (NYHA) class III or IV heart failure
  • Patients with the following histories allowed provided they are asymptomatic with respect to cardiac function and LVEF is normal by MUGA at baseline: Anthracycline exposure, Central thoracic radiation that included the heart, NYHA class II cardiac function
  • No uncontrolled hypertension (i.e., systolic blood pressure >= 140 mm Hg or diastolic blood pressure >= 90 mm Hg)
  • No cardiac disease within the past 12 months, including any of the following: myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure
  • No pulmonary embolism within the past 12 months
  • No cerebrovascular accident or transient ischemic attack within the past 12 months
  • No bowel obstruction or any condition that would impair the ability to swallow and retain sunitinib malate, including any of the following:

gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, active peptic ulcer disease

  • No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following: history of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance with study requirements, Active uncontrolled infection, Any other medical condition that might be aggravated by treatment, OR;
  • Serious or nonhealing wound, ulcer, or bone fracture, Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No pre-existing hypothyroidism unless euthyroid on medication
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: Azole antifungals (e.g., ketoconazole, itraconazole, miconazole), Verapamil, Clarithromycin, HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir) Erythromycin, Delavirdine, Diltiazem
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: Rifampin, Phenytoin, Rifabutin, Hypericum perforatum (St. John's wort), Carbamazepine, Efavirenz Phenobarbital, Tipranavir
  • At least 4 weeks since prior major surgery and recovered
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 12 months since prior coronary/peripheral artery bypass graft or stenting
  • No prior surgical procedures affecting absorption
  • No prior radiotherapy that involved >= 30% of functioning bone marrow
  • No prior treatment with any other antiangiogenic agents or multitargeted tyrosine kinase inhibitors, including any of the following:

bevacizumab, sorafenib tosylate, pazopanib, thalidomide, AZD2171, vandetanib, AMG706, vatalanib, VEGF Trap

  • No prior angiogenesis inhibitors except epidermal growth factor receptor inhibitors or other noncytotoxic therapy
  • No other concurrent anticancer therapy or treatment with other investigational anticancer agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin); Doses =< 2 mg/day for prophylaxis of thrombosis or low molecular weight heparin for patients with an INR < 1.5 are allowed
  • No concurrent agents with proarrhythmic potential, including any of the following: terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392444
Other Study ID Numbers  ICMJE NCI-2009-00693
NCI-2009-00693 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000652058
NCIC-183 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-183 ( Other Identifier: CTEP )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Laurie Canadian Cancer Trials Group
PRS Account National Cancer Institute (NCI)
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP