Full Text View
Tabular View
No Study Results Posted
Related Studies
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
This study is ongoing, but not recruiting participants.
Study NCT00030459   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes

February 14, 2002
July 23, 2008
November 2000
 
 
 
Complete list of historical versions of study NCT00030459 on ClinicalTrials.gov Archive Site
 
 
 
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma

RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.

PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.

OBJECTIVES:

  • Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma.
  • Determine the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.

  • Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques).
  • Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
  • Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14.

Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.

Phase II
Interventional
Treatment, Randomized, Active Control
Malignant Mesothelioma
  • Drug: cisplatin
  • Drug: mitomycin C
  • Drug: vinblastine
  • Drug: vinorelbine ditartrate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Immunohistochemically or cytologically confirmed malignant mesothelioma

    • Epithelial and other histological types
  • Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
  • Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Considered medically fit to receive chemotherapy
  • No other disease or prior malignancy that would preclude study
  • No clinical evidence of infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for mesothelioma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00030459
 
CDR0000069167, BTS-MESO-1, MRC-BTS-MESO-1, EU-20134
British Thoracic Society
Medical Research Council
Study Chair: Martin F. Muers, MD Leeds General Infirmary
Study Chair: David J. Girling, MD Medical Research Council
National Cancer Institute (NCI)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP