Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: cisplatin
• Drug: mitomycin C
• Drug: vinblastine
• Drug: vinorelbine ditartrate

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: British Thoracic Society

Overall Clinical Trial Officials and Contacts

Martin F. Muers, MD Study Chair Leeds General Infirmary  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00030459

Study ID Number: CDR0000069167

ClinicalTrials.gov Identifier: NCT00030459

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database