Malignant Mesothelioma
Conditions
Keywords
epithelial mesothelioma, localized malignant mesothelioma, advanced malignant mesothelioma
Brief summary
RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy. PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.
Detailed description
OBJECTIVES: Primary * Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine. Secondary * Compare the toxic effects of these regimens in these patients. * Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens. * Compare the performance status of patients treated with these regimens. * Compare analgesic usage in patients treated with these regimens. * Compare the tumor response and progression-free survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required. * Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses. * Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses. Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter. Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.
Interventions
DRUGvincristine sulfate
DRUGvinorelbine tartrate
DRUGmitomycin C
DRUGcisplatin
PROCEDUREpain therapy
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
Medical Research Council
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically and immunohistochemically confirmed malignant pleural mesothelioma * Epithelial and other histological types are allowed * No more than 3 months since diagnosis * Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy * Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Not specified Renal * Creatinine clearance \> 50 mL/min Pulmonary * See Disease Characteristics Other * Not pregnant or nursing * Fertile patients must use effective contraception * Considered medically fit to receive chemotherapy * No other disease or prior malignancy likely to interfere with protocol treatments or comparisons * No clinical evidence of infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for mesothelioma Endocrine therapy * Not specified Radiotherapy * Prior local radiotherapy to a wound site after exploratory thoracotomy allowed Surgery * See Disease Characteristics * See Radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance status as measured by WHO grade | — |
| Analgesic usage | — |
| Toxicity as measured by the NCIC CTC | — |
| Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks | — |
| Tumor response as measured by the RECIST criteria | — |
| Progression-free survival as measured by CT scan | — |
| Quality of life as assessed by the European Organization for Research and Treatment of Cancer | — |
Countries
United Kingdom
Outcome results
None listed