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A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma

Phase 2
18 Years
Not Enrolling
Advanced Malignant Mesothelioma, Recurrent Malignant Mesothelioma

Thank you

Trial Information

A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma


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.

Inclusion 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (partial and complete) per RECIST

Outcome Description:

The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Scott Laurie

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCIC Clinical Trials Group


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Mesothelioma