Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

Medical Research Council840 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Malignant Mesothelioma

Interventions

cisplatinDRUG

mitomycin CDRUG

vincristine sulfateDRUG

vinorelbine tartrateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

Saint Bartholomew's Hospital

London, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Outcomes

Primary Outcomes

Overall survival

Secondary Outcomes

Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks

Performance status as measured by WHO grade

Analgesic usage

Toxicity as measured by the NCIC CTC

Quality of life as assessed by the European Organization for Research and Treatment of Cancer

Tumor response as measured by the RECIST criteria

Progression-free survival as measured by CT scan

Data from ClinicalTrials.gov

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