Clinical trial NCT00030459: Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Official title: Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Mesothelioma
Keywords: localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Medical Research Council
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Princess Royal Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital Trust
state: England
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Medical Research Council Clinical Trials Unit
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Glasgow
country: United Kingdom
facility: Stobhill General Hospital
state: Scotland
city: Bradford-Onavon
country: United Kingdom
facility: Dorothy House Foundation
city: Chertsey Surrey
country: United Kingdom
facility: St. Peters Hospital
Study officials:
affiliation: Leeds General Infirmary
name: Martin F. Muers, MD
role: STUDY_CHAIR
affiliation: Medical Research Council
name: David J. Girling, MD
role: STUDY_CHAIR
References: