- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00392444
Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- National Cancer Institute of Canada Clinical Trials Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response (Partial and Complete) Per RECIST
Time Frame: Up to 3 years
|
Number of patients who had objective responses after radiology review
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Laurie, Canadian Cancer Trials Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- NCI-2009-00693 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000652058
- NCIC-183 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Malignant Mesothelioma
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma | Unresectable Solid Neoplasm | Advanced Pleural Malignant Mesothelioma | Advanced Peritoneal Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedCediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By SurgeryRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingEpithelioid Mesothelioma | Pleural Malignant Mesothelioma | Sarcomatoid Mesothelioma | Recurrent Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous MesotheliomaUnited States
Clinical Trials on sunitinib malate
-
PfizerCompletedGastrointestinal Stromal TumorsKorea, Republic of
-
PfizerCompletedGastrointestinal Stromal TumorsUnited States, Czechia, France
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedKidney CancerUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedRenal Cell Carcinoma | Gastrointestinal Stromal Tumors | Pancreatic Neuroendocrine TumorChina
-
Icahn School of Medicine at Mount SinaiPfizerCompleted
-
PfizerCompletedCarcinoma, Renal CellUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerActive, not recruitingSunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal MelanomaCiliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage IIIC Intraocular Melanoma | Stage I Intraocular Melanoma | Stage IIA Intraocular Melanoma | Stage IIB Intraocular... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Metastatic Kidney CarcinomaUnited States
-
Tony Bekaii-SaabPfizerCompletedEsophageal CancerUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States