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Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
This study has been completed.

First Received on October 25, 2006.   Last Updated on January 9, 2012   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): NCIC Clinical Trials Group
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Objective response (partial and complete) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Disease is measured at the end of every cycle.


Enrollment: 39
Study Start Date: November 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib
50mg orally daily for 4 out of 6 weeks.
Drug: sunitinib malate
50mg orally daily for 4 our of 6 weeks.

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 until progression and treatment related toxicities resolve.

  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
  • 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
  • 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
    • Coronary/peripheral artery bypass graft or stenting
    • 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 prior surgical procedures affecting absorption.
  • 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
  • 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, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada
University Institute of Cardiology and
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Scott A. Laurie, MD, FRCPC Ottawa Regional Cancer Centre
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00392444     History of Changes
Other Study ID Numbers: I183, CAN-NCIC-IND183, CDR0000509318
Study First Received: October 25, 2006
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
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