Malignant Mesothelioma
Conditions
Keywords
recurrent malignant mesothelioma, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
Brief summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
Detailed description
OBJECTIVES: Primary * Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate. Secondary * Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate. * Assess safety and toxicity in these patients. * Assess quality of life using the Lung Cancer Symptom Score. OUTLINE: This is a multicenter study. Patients are stratified according to current treatment (first-line vs second-line) Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients exhibiting objective response or stable disease by week 20, may continue treatment at the discretion of the investigator until evidence of disease progression. Quality of life is assessed periodically. After completion of study treatment, patients are followed for up to 2 years. PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.
Interventions
DRUGbortezomib
PROCEDUREquality-of-life assessment
Sponsors
Cancer Trials Ireland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed malignant pleural mesothelioma * Meets 1 of the following criteria for first-line or second-line chemotherapy: * Patients in the first-line setting must be unsuitable for, cannot access locally, or refuse combination chemotherapy * Patients in the second-line setting must be unsuitable for, cannot access locally, or refuse cytotoxic chemotherapy after failure of a first-line regimen * Second-line patients may not have received more than 1 prior line of antineoplastic treatment for this cancer * Pleural effusions should be drained before treatment whenever possible * Talc or tetracycline pleurodesis may be used per standard practice for uncontrollable pleural effusions (recurrent despite regular drainage)
Exclusion criteria
* Symptomatic or known brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Hemoglobin ≥ 10 g/dL * Neutrophil count ≥ 1,500 mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance ≥ 30 mL/min * AST and ALT \< 3 times upper limit of normal * Fertile patients must use effective contraception during study therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria | 28 days prior to baseline, at 10 weeks and at end of treatment | The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression | Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment. | — |
| Overall survival | Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive. | — |
| Safety | The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges. | — |
| Quality of life | Week 1, Week 10 and end of treatment | Quality of life will be assessed using the Lung Cancer Symptom Score |
Countries
Belgium, Ireland, Netherlands, United Kingdom
Outcome results
None listed