This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria. II. Determine the clinical toxicities of this drug in this patient population. SECONDARY OBJECTIVES: I. Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria. II. Determine the response rate in patients treated with this drug. III. Determine the effect of this drug on overall survival and time to progression in these patients. IV. Assess predictive markers of activity of this drug in these patients. V. Assess serologic markers of target inhibition by this drug in these patients. VI. Determine the clinical toxicities of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis. After completion of study therapy, patients are followed every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Correlative study
Given orally
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)
The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.
Time frame: 6 months
Overall Survival
Time frame: From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years
Progression-free Survival Assessed by RECIST
Time frame: From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years
Determine the Clinical Toxicities of This Drug in This Participant Population.
The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.
Time frame: Participants will be evaluated every cycle during treatment
Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD.
Time frame: From study enrollment to the first date of disease progression
Overall Response Rate
To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
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Time frame: Participants will be evaluated every cycle during treatment, up to 2 years