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

Malignant Mesothelioma Clinical Trial

Official title:

A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075699
• Other study ID #: BTS-MRC-MS01
• Secondary ID: CDR0000347461ISR
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2004
• Last updated: August 6, 2013
• Start date: September 2003

Study information

• Verified date: June 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• cisplatin

• mitomycin C

• vincristine sulfate

• vinorelbine tartrate

Procedure:
• pain therapy

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Muers M, Fisher P, Snee M, et al.: A randomized phase III trial of active symptom control (ASC) with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma: first results of the Medical Research Council (MRC) / British Th

Muers MF, Rudd RM, O'Brien ME, Qian W, Hodson A, Parmar MK, Girling DJ; British Thoracic Society Mesothelioma Group. BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112. Thorax. 2004 Feb;59(2):144-8. — View Citation

Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the — View Citation

Qian W, Muers MF, Rudd RM, et al.: A feasibility study of active symptom control (ASC) with or without chemotherapy in malignant pleural mesothelioma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2568, 639, 2003.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks			No
Secondary	Performance status as measured by WHO grade			No
Secondary	Analgesic usage			No
Secondary	Toxicity as measured by the NCIC CTC			Yes
Secondary	Quality of life as assessed by the European Organization for Research and Treatment of Cancer			No
Secondary	Tumor response as measured by the RECIST criteria			No
Secondary	Progression-free survival as measured by CT scan			No