Mesothelioma Clinical Trials
Active Symptom
Control With or Without Chemotherapy in Treating Patients With
Malignant Pleural Mesothelioma
This study is currently
recruiting patients.
British Thoracic Society
For more information:National
Cancer Institute (NCI)
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: Randomizedphase III trial to compare the
effectiveness of active symptom control with or without
chemotherapy in treating patients who have malignant pleural
mesothelioma.
Condition
|
Treatment or
Intervention |
epithelial
mesothelioma localized malignant
mesothelioma advanced malignant mesothelioma |
Drug: cisplatin Drug: mitomycin Drug: vincristine Drug: vinorelbine Procedure: chemotherapy Procedure: pain
therapy Procedure: psychosocial
assessment/care Procedure: quality-of-life
assessment Procedure: supportive
care/therapy
|
This is a Phase III test
- In Phase III studies, the study
drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side
effects, compare it to commonly used treatments, and collect information that will allow
the drug or treatment to be used safely.
Study Type: Interventional Study
Design: Treatment
Official Title: Phase III Randomized
Study of Active Symptom Control With Versus Without
Chemotherapy in Patients With Malignant Pleural
Mesothelioma
Further Study Details:
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.
PROJECTED ACCRUAL: A total of 840 patients (280 per
treatment arm) will be accrued for this study within 4
years.
Ages Eligible for Study: 18 Years and
above, Genders Eligible for Study: Both
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
|