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Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: National Cancer Institute of Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00392444
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura.


Condition Intervention Phase
Malignant Mesothelioma
Drug: sunitinib malate
Phase II

MedlinePlus related topics:   Cancer    Mesothelioma   

ChemIDplus related topics:   Sunitinib    Sunitinib malate    Malic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label
Official Title:   A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma

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

Primary Outcome Measures:
  • Objective response (partial and complete) [ Designated as safety issue: No ]

Estimated Enrollment:   57
Study Start Date:   September 2006
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Assess the efficacy of sunitinib malate, in terms of response rate (complete and partial), in patients with malignant pleural mesothelioma.
  • Assess the toxicity, safety, and tolerability of this drug in these patients.
  • 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.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study.

  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 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 teachniques 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

PATIENT CHARACTERISTICS:

  • 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
    • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392444

Locations
Canada
L'Hopital Laval     Recruiting
      Quebec, Canada, G1V 4G5
      Contact: Francis Laberge     418-656-4747        
Canada, Alberta
Cross Cancer Institute at University of Alberta     Recruiting
      Edmonton, Alberta, Canada, T6G 1Z2
      Contact: Quincy Chu     780-432-8248        
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre     Recruiting
      Surrey, British Columbia, Canada, V3V 1Z2
      Contact: Christopher Lee     604-930-4017        
British Columbia Cancer Agency - Centre for the Southern Interior     Recruiting
      Kelowna, British Columbia, Canada, V1Y 5L3
      Contact: Delia Sauciuc     250-712-3900        
British Columbia Cancer Agency - Vancouver Cancer Centre     Recruiting
      Vancouver, British Columbia, Canada, V5Z 4E6
      Contact: Nevin Murray     604-877-6000        
Canada, Nova Scotia
Nova Scotia Cancer Centre     Recruiting
      Halifax, Nova Scotia, Canada, B3H 1V7
      Contact: Wojciech Morzycki     902-473-8317        
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre     Recruiting
      Hamilton, Ontario, Canada, L8V 5C2
      Contact: John Goffin     905-387-9495        
Ottawa Hospital Regional Cancer Centre - General Campus     Recruiting
      Ottawa, Ontario, Canada, K1H 8L6
      Contact: Scott Laurie     613-737-7700        
Princess Margaret Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 2M9
      Contact: Ronald Feld     416-946-2260        

Sponsors and Collaborators
National Cancer Institute of Canada
National Cancer Institute (NCI)

Investigators
Study Chair:     Scott A. Laurie, MD, FRCPC     Ottawa Hospital Regional Cancer Centre - General Campus    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000509318, CAN-NCIC-IND183
First Received:   October 25, 2006
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00392444
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
recurrent malignant mesothelioma  

Study placed in the following topic categories:
Sunitinib
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Mesothelial
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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