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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075699
First received: January 9, 2004
Last updated: August 6, 2013
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Malignant Mesothelioma
Drug: cisplatin
Drug: mitomycin C
Drug: vincristine sulfate
Drug: vinorelbine tartrate
Procedure: pain therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks [ Designated as safety issue: No ]
  • Performance status as measured by WHO grade [ Designated as safety issue: No ]
  • Analgesic usage [ Designated as safety issue: No ]
  • Toxicity as measured by the NCIC CTC [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the European Organization for Research and Treatment of Cancer [ Designated as safety issue: No ]
  • Tumor response as measured by the RECIST criteria [ Designated as safety issue: No ]
  • Progression-free survival as measured by CT scan [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075699

Locations
United Kingdom
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS1 3EX
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medical Research Council
Investigators
Principal Investigator: Martin F. Muers, MD Leeds General Infirmary
  More Information

Additional Information:
Publications:
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 Thoracic Society (BTS) MS01 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA7525, 390s, 2007.
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.

ClinicalTrials.gov Identifier: NCT00075699     History of Changes
Other Study ID Numbers: BTS-MRC-MS01, CDR0000347461, ISRCTN54469112, EU-20349
Study First Received: January 9, 2004
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
epithelial mesothelioma
localized malignant mesothelioma
advanced malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Mitomycins
Mitomycin
Vinorelbine
Cisplatin
Vincristine
Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014