Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma

NCT00030459 | Unknown Phase 2

• 4 other identifiers: BTS-MESO-1CDR0000069167MRC-BTS-MESO-1EU-20134
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Interventions

cisplatin DRUG

mitomycin C DRUG

vinblastine sulfate DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• British Thoracic Society: lead
• Medical Research Council: collaborator

Study Sites (9)

Princess Royal Hospital

Hull, England, HU8 9HE, United Kingdom

Location

Leeds Teaching Hospital Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Stobhill General Hospital

Glasgow, Scotland, G21 3UW, United Kingdom

Location

Dorothy House Foundation

Bradford-Onavon, BA15 2LE, United Kingdom

Location

St. Peters Hospital

Chertsey Surrey, KT 16 OPZ, United Kingdom

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Cisplatin; Mitomycin; Vinblastine; Vinorelbine

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indolizidines; Indolizines

Study Officials

• Martin F. Muers, MD

  Leeds General Infirmary

  STUDY CHAIR

• David J. Girling, MD

  Medical Research Council

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: November 1, 2000
• Last Updated: August 7, 2013

Record last verified: 2003-05

Locations

GB (9)