Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

NCT00392444 | Completed Phase 2 Results

• 3 other identifiers: NCI-2009-00693CDR0000652058NCIC-183
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Mesothelioma; Recurrent Malignant Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Objective Response (Partial and Complete) Per RECIST

  Number of patients who had objective responses after radiology review

  Up to 3 years

Study Arms (1)

Treatment (sunitinib malate)

EXPERIMENTAL

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.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute of Canada Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Scott Laurie
• Organization: The Ottawa Hospital Cancer Centre

slaurie@toh.on.ca

613-737-7700

Study Officials

• Scott Laurie

  Canadian Cancer Trials Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: February 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 21, 2014
• Results First Posted: December 13, 2013

Record last verified: 2013-04

Locations

CA (1)