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

Malignant Mesothelioma Clinical Trial

Official title:

Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00030459
• Other study ID #: BTS-MESO-1
• Secondary ID: CDR0000069167MRC
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: August 6, 2013
• Start date: November 2000

Study information

• Verified date: May 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• cisplatin

• mitomycin C

• vinblastine sulfate

• vinorelbine tartrate

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Dorothy House Foundation	Bradford-Onavon
United Kingdom	St. Peters Hospital	Chertsey Surrey
United Kingdom	Stobhill General Hospital	Glasgow	Scotland
United Kingdom	Princess Royal Hospital	Hull	England
United Kingdom	Leeds Teaching Hospital Trust	Leeds	England
United Kingdom	Medical Research Council Clinical Trials Unit	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Royal Marsden Hospital	Sutton	England

Sponsors (2)

Lead Sponsor	Collaborator
British Thoracic Society	Medical Research Council

Country where clinical trial is conducted

United Kingdom,