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

United Kingdom Research and Innovation (UKRI)

Status and phase

Completed

Phase 3

Conditions

Malignant Mesothelioma

Treatments

Drug: vinorelbine tartrate

Procedure: pain therapy

Drug: mitomycin C

Drug: cisplatin

Drug: vincristine sulfate

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Study type

Interventional

Funder types

Other

Identifiers

NCT00075699

BTS-MRC-MS01

CDR0000347461 (Registry Identifier)

EU-20349

ISRCTN54469112

Details and patient eligibility

About

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.

Full 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.

Enrollment

840 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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