Phase III Randomized Study of Active Symptom Control With Versus Without Chemotherapy in Patients With Malignant Pleural Mesothelioma
(Summary Last Modified October 12,2005)
http://www.clinicaltrials.gov/ct/show/NCT00075699?amp;order=3
Active Symptom Control With or Without Chemotherapy 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.
PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.
Entry 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
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
Patient Characteristics:
Age
-
18 and over
Performance status
-
WHO 0-2
Life expectancy
-
Not specified
Hematopoietic
-
WBC > 3,000/mm3
-
Absolute neutrophil count > 1,500/mm3
-
Platelet count > 100,000/mm3
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
Disclaime
The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations
British Thoracic Society
Martin Muers, MD, Principal investigator
Ph: 44-113-243-2799
Trial Sites and Contacts
United Kingdom
England
Leeds
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Martin Muers, MD
Ph: 44-113-243-2799
London
Saint Bartholomew's Hospital
Robin Rudd, MD
Ph: 44-20-7377-7000
Email: R.M.Rudd@mds.qmw.ac.uk
Sutton
Royal Marsden Hospital - Sutton
Mary O'Brien, MD
Ph: 44-20-8642-6011
Email: maryo@icr.ac.uk
*** POSTED DECEMBER 2003 ***
*** RE-POSTED NOVEMBER 9, 2005 ***