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

Brief Title

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

Official Title

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

Brief 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.

Detailed 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

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

Condition

Malignant Mesothelioma

Intervention

cisplatin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2003

Eligibility 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

          -  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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martin F. Muers, MD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT00075699

Organization ID

BTS-MRC-MS01

Secondary IDs

CDR0000347461

Study Sponsor

Medical Research Council

Study Sponsor

Martin F. Muers, MD, Principal Investigator, Leeds General Infirmary

Verification Date

June 2008